Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)
Verified date | April 2024 |
Source | EMD Serono |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | May 27, 2024 |
Est. primary completion date | May 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks - Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria: - Radiological documentation of disease progression on first-line osimertinib - Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (>) 6 months after initiation of osimertinib - Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting - MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening - Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing - Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention - Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia - Inadequate hematological, liver and renal function - Impaired cardiac function - History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment - Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 millimeter of mercury (mmHg) - Contraindication to the administration of osimertinib - Other protocol defined exclusion criteria could apply. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Antwerpen - Department of Oncology | Edegem | |
Belgium | UZ Leuven | Gasthuisberg | |
Belgium | AZ Delta | Roeselare | |
China | Beijing Hospital | Beijing | |
China | Peking Union Medical College Hospital | Beijing | |
China | Peking University Cancer Hospital | Beijing | |
China | Jilin Cancer Hospital - Oncology | Changchun | |
China | The First Hospital of Jilin University | Changchun | |
China | Hunan Cancer Hospital | Changsha | |
China | West China Hospital, Sichuan University | Chengdu | |
China | Fujian Cancer Hospital | Fuzhou | |
China | Guangdong General Hospital | Guangzhou | |
China | The First Affiliated Hospital, Zhejiang University | Hangzhou | |
China | Zhejiang Cancer Hospital | Hangzhou | |
China | Affiliated Tumor Hospital of Harbin Medical University | Harbin | |
China | Anhui Chest Hospital | Hefei | |
China | Linyi Tumor Hospital | Linyi | |
China | Jiangsu Province Hospital | Nanjing | |
China | Shanghai Cancer Hospital, Fudan University | Shanghai | |
China | Shanghai Chest Hospital | Shanghai | |
China | Liaoning Cancer Hospital & Institute | Shenyang | |
China | The Affiliated Cancer Hospital of Xinjiang Medical university | Urumqi | |
China | Hubei Cancer Hospital | Wuhan | |
China | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | |
France | Centre Francois Baclesse - Service d'Oncologie Medicale | Caen Cedex 05 | |
France | Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie | Creteil Cedex | |
France | CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée | Limoges | |
France | Centre Léon Bérard | Lyon | |
France | Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie | Nord | |
France | Hopital Tenon - service pneumologie | Paris | |
France | Hospital Cochin Service, Service de Pneumologie et Mucoviscidose | Paris cedex 14 | |
France | Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha | Pessac | |
France | CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique | Toulouse | |
Germany | Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | |
Germany | Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie | Gauting | |
Germany | Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Giessen | |
Germany | Universitaetsmedizin Goettingen | Göttingen | |
Germany | Evangelisches Krankenhaus Hamm gGmbH | Hamm | |
Germany | Evangelisches Krankenhaus Hamm GmbH | Hamm | |
Germany | Thoraxklinik-Heidelberg gGmbH | Heidelberg | |
Germany | Staedtisches Krankenhaus Kiel | Kiel | |
Germany | Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie | Koeln | |
Germany | POIS Leipzig GbR | Leipzig | |
Germany | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Luebeck | |
Germany | Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie | Oldenburg | |
Germany | Missionsärztliche Klinik | Wuerzburg | |
Hong Kong | Queen Elizabeth Hospital - Department of Medicine | Hong Kong | |
Hong Kong | The University of Hong Kong | Hong Kong | |
Hong Kong | The Chinese University of Hong Kong - Emergency Medicine | Shatin | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica | Lazio | |
Italy | IEO Istituto Europeo di Oncologia | Milano | |
Italy | Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica | Monza | |
Italy | Ospedale Monaldi | Napoli | |
Italy | IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2 | Padova | |
Italy | AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia | Palermo | |
Italy | Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II | Pisa | |
Italy | Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B | Roma | |
Italy | Istituto Clinico Humanitas | Rozzano | |
Italy | Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica | Varese | |
Italy | Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia | Verona | |
Japan | Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine | Hamamatsu-shi | |
Japan | Saitama Cancer Center | Kitaadachi-gun | |
Japan | Kurume University Hospital | Kurume-shi | |
Japan | Nagoya University Hospital - Dept of Respiratory Medicine | Nagoya-shi | |
Japan | Niigata Cancer Center Hospital - Dept of Internal Medicine | Niigata-shi | |
Japan | Hyogo College of Medicine Hospital - Dept of Respiratory Medicine | Nishinomiya-shi | |
Japan | Okayama University Hospital - Dept of Respiratory Medicine/Allergy | Okayama-shi | |
Japan | Osaka City General Hospital | Osaka-shi | |
Japan | Kindai University Hospital | Osakasayama-shi | |
Japan | NHO Yamaguchi - Ube Medical Center | Ube-shi | |
Japan | Kanagawa Cancer Center - Dept of Respiratory Medicine | Yokohama-shi | |
Korea, Republic of | National Cancer Center | Goyang-si | |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun-gun | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Malaysia | Pantai Hospital Kuala Lumpur | Kuala Lumpur | |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Malaysia | Hospital Tengku Ampuan Afzan | Kuantan | |
Malaysia | Hospital Umum Sarawak | Kuching | |
Malaysia | Sunway Medical Centre | Petaling Jaya, Selangor | |
Malaysia | Hospital Pulau Pinang - Clinic Respiratory | Pulau Pinang | |
Malaysia | Beacon International Specialist Centre Sdn Bhd | Selangor | |
Netherlands | The Netherlands Cancer Institute | Amsterdam | |
Netherlands | Universitair Medisch Centrum Groningen - Department of Internal Medicine | Groningen | |
Netherlands | Maastricht University Medical Center - Dept of Medical Oncology | Maastricht | |
Russian Federation | SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky" | Krasnoyarsk | |
Russian Federation | "VitaMed" LLC | Moscow | |
Russian Federation | LLC "Tonus" | Nizniy Novgorod | |
Russian Federation | BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | |
Russian Federation | LLC "ClinicaUZI4D" | Pyatigorsk | |
Russian Federation | FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint-Petersburg | |
Russian Federation | Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology | St. Petersburg | |
Singapore | Icon Cancer Centre | Connexion | |
Singapore | National Cancer Centre - Medical Oncology Pharmacy | Singapore | |
Singapore | Tan Tock Seng Hospital - CTRU/OCS, Research | Singapore | |
Spain | ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica | Badalona | |
Spain | Hospital del Mar - Servicio de Oncologia | Barcelona | |
Spain | Hospital Universitari Dexeus - Servicio de Oncologia Medica | Barcelona | |
Spain | Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica | Barcelona | |
Spain | Hospital Universitari Vall d'Hebron - Dept of Oncology | Barcelona | |
Spain | ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia | L'Hospitalet de Llobregat | |
Spain | Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia | Las Palmas de Gran Canaria | |
Spain | Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia | Madrid | |
Spain | Hospital Regional Universitario de Malaga | Málaga | |
Spain | Hospital Universitari Son Espases - Servicio de Oncologia Medica | Palma | |
Spain | Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia | Pozuelo de Alarcon | |
Spain | Hospital Universitario Virgen Macarena - Servicio de Oncologia | Sevilla | |
Spain | Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica | Valencia | |
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | Chi Mei Medical Center, Liou Ying | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
Thailand | Siriraj Hospital | Bangkoknoi | |
Thailand | Songklanagarind Hospital | Hat Yai | |
Thailand | Maharaj Nakorn Chiang Mai Hospital | Muang | |
Thailand | King Chulalongkorn Memorial Hospital | Pathumwan | |
United States | University Cancer and Blood Center | Athens | Georgia |
United States | Medstar Franklin Square Clinical Research Center | Baltimore | Maryland |
United States | New Jersey Cancer Care and Blood Disorders | Belleville | New Jersey |
United States | The Center for Cancer & Blood Disorders - Maryland | Bethesda | Maryland |
United States | Central Care Cancer Center (CCCC) | Bolivar | Missouri |
United States | Boston Medical Center - Dept. Hematology/Oncology | Boston | Massachusetts |
United States | St. Louis Cancer Care, LLP | Bridgeton | Missouri |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University Hospitals Seidman | Cleveland | Ohio |
United States | OhioHealth | Columbus | Ohio |
United States | Mary Crowley Cancer Research | Dallas | Texas |
United States | Southcoast Center for Cancer Care | Fairhaven | Massachusetts |
United States | Summit Medical Group | Florham Park | New Jersey |
United States | Holy Cross | Fort Lauderdale | Florida |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Compassionate Care Research Group Inc - Edinger Medical Group, Inc. | Fountain Valley | California |
United States | Frederick Health- James M Stockman Cancer Institute | Frederick | Maryland |
United States | Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia |
United States | Gettysburg Cancer Center | Gettysburg | Pennsylvania |
United States | Southeastern Medical Oncology Center | Goldsboro | North Carolina |
United States | Pontchartrain | Hammond | Louisiana |
United States | Memorial Healthcare System | Hollywood | Florida |
United States | Hawaii Cancer Care | Honolulu | Hawaii |
United States | University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology | Houston | Texas |
United States | Community Health Network | Indianapolis | Indiana |
United States | Cancer Specialists of North Florida | Jacksonville | Florida |
United States | Sparrow Hospital Herbert - Herman Cancer Center | Lansing | Michigan |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Memorial Care | Long Beach | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | Baptist Cancer Center | Memphis | Tennessee |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | NYU Langone Clinical Cancer Center - NYU Langone Medical Cente | New York | New York |
United States | NYU Langone Clinical Cancer Center - NYU Langone Medical Center | New York | New York |
United States | Weill Cornell Medical College - Gastroenterology | New York | New York |
United States | Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut |
United States | Ocala Oncology | Ocala | Florida |
United States | Community Cancer Trials of Utah | Ogden | Utah |
United States | Ventura County Hematology Oncology Specialists | Oxnard | California |
United States | Mosaic Life Care | Saint Joseph | Missouri |
United States | Oregon Oncology Specialists | Salem | Oregon |
United States | Utah Cancer Specialists | Salt Lake City | Utah |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Sanford Health | Sioux Falls | South Dakota |
United States | Beacon Health | South Bend | Indiana |
United States | Northwest Medical Specialties | Tacoma | Washington |
United States | Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma |
United States | Innovative Clinical Research Institute | Whittier | California |
United States | Yuma Regional Medical Center | Yuma | Arizona |
Vietnam | Bach Mai Hospital | Hanoi | |
Vietnam | K Hospital | Hanoi | |
Vietnam | National Lungs Hospital | Hanoi | |
Vietnam | Cho Ray Hospital | Ho Chi Minh City | |
Vietnam | HCMC Oncology Hospital | Ho Chi Minh city | |
Vietnam | Pham Ngoc Thach Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany |
United States, Vietnam, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Russian Federation, Singapore, Spain, Taiwan, Thailand,
F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0) | DLTs are defined as any of the following toxicities and judged by the Investigator and/or the Sponsor to be not attributable to the disease or disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (>=) 3 febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade >= 3 nausea/vomiting and/or diarrhea that has not improved within 72 hours despite adequate and optimal treatment; Any other Grade >= 3 non-hematological AE, except alopecia or Grade 3 nauseas/vomiting and/or diarrhea that has improved within 72 hours with optimal treatment. | Up to Day 21 of Cycle 1 (each Cycle is of 21 days) | |
Primary | Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH) | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1 as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Related TEAEs | The laboratory measurements included hematology, biochemistry, coagulation and urinalysis. Number of participants with clinically significant abnormalities in laboratory values reported as treatment related TEAEs were reported. Clinical significance was decided by investigator. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Number of Participants With Markedly Abnormal Vital Sign Measurements | Vital signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR), respiratory rate (RR) body weight (BW) and body temperature (BT). Markedly abnormal value (MAV) criteria for vital signs: SBP and DBP: maximal on treatment (TR) increase or decrease greater than (>) 40 millimeter of mercury (mmHg); PR: maximal on TR increase or decrease >40 beats per minute (bpm); RR: maximal on TR increase or decrease >10 breaths per minute (breaths/minute), BW: maximum on TR increase or decrease >=10% and BT: maximal on TR increase greater than or equal to (>=)2 degree Celsius. Number of participants who met the MAV criteria for vital signs at least once post dose were reported. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score | ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0 = Fully active, able to carry on all pre-disease activities without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; 3 = Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4 = Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5 = dead. ECOG performance status was reported in terms of number of participants with shifts in score from baseline value vs worst post-baseline value (that is [i.e.] highest score). | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings | Electrocardiograms (ECG) was obtained after the participant has been in a semi-supine position for at least 5 min. ECG parameters included heart rate, PQ/PR duration, QRS and QT duration, QT Interval. Clinical significance was determined by the investigator. Number of participants with clinically significant abnormalities in 12-lead ECG were reported. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1 Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Assessed by the Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by FISH | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Overall Survival in Participants With MET Amplification Determined Centrally by FISH | Overall survival is defined as the time from first administration of study treatment to the date of death. | Time from first administration of study treatment to the date of death, assessed approximately up to 42 months | |
Secondary | Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy ((Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Overall Survival in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing | Overall survival is defined as the time from first administration of study treatment to the date of death. | Time from first administration of study treatment to the date of death, assessed approximately up to 42 months | |
Secondary | Monotherapy (Tepotinib): Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Investigator in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH) | Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | Confirmed CR was defined as the disappearance of all evidence of target and non-target lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Monotherapy (Tepotinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Monotherapy (Tepotinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH | Disease control rate is defined as the percentage of participants with objective resposne (complete resposne [CR] or partial resposne [PR] or stable disease [SD]). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months) | |
Secondary | Monotherapy (Tepotinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Monotherapy (Tepotinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by FISH | PFS was defined as the time is defined as the time from first administration of study treatment to the date of the first documentation of PD or death due to any cause within 126 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Safety Follow-up (42 Months) | The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine. | Baseline, safety follow-up (assessed up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status) at Safety Follow-up (42 Months) | EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Baseline, safety follow-up (up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in Health-Related Quality of Life as Assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) at Safety Follow-up (42 Months) | NSCLC-SAQ was a question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 5 domains: cough, pain, dyspnea, fatigue, and appetite. The NSCLC-SAQ score ranged from 0 to 20; High score indicated more severe NSCLC-related symptomatology. mains: cough, pain, dyspnea, fatigue, and appetite. | Baseline, safety follow-up (up to 42 months) | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104 | Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. | Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ] | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Maximum Observed Plasma Concentration (Cmax) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104 | Cmax was obtained directly from the concentration versus time curve. | Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ] | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104 | Tmax was obtained directly from the concentration versus time curve. | Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ] | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Apparent Total Body Clearance (CL/f) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104 | CL/f was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. CL/f was calculated as Dose/AUC0-inf, where AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. AUC0-inf was calculated as AUC0-t + Clast pred/Lambda Z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the lower limit of quantification (LLQ) and Lambda Z was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve. | Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ] | |
Secondary | Combined Therapy (Tepotinib + Osimertinib): Apparent Volume Of Distribution (Vz/F) of of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104 | Vz/f: the distribution of a study drug between plasma and the rest of the body after oral dosing. For single dose Vz/f = Dose/(AUC0-inf*Lambda Z), where AUC0-inf = (AUC0-t + Clast pred/Lambda Z). Clastpred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and Lambda Z = the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve. | Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ] | |
Secondary | Percentage of Participants With Resistant Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene or Other Pathways as Assessed in Circulating Tumor Deoxyribonucleic Acid (ctDNA) | Percentage of participants with resistant mutations of the EGFR gene or other pathways as assessed in ctDNA were reported. | From Day 1 of Cycle 3 up to end of treatment (14 days after last dose, approximately assessed up to 35.6 months) (each Cycle is for 21 days) |
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