A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03940703
• Other study ID #: MS200095_0031
• Secondary ID: 2019-001538-33
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 19, 2019
• Est. completion date: May 27, 2024

Study information

• Verified date: April 2024
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tepotinib
Participants were administered with Tepotinib orally once daily at a dose of 500 mg.
• Osimertinib
Participants received Osimertinib at a dose of 80 mg orally once daily.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Vietnam,  Belgium,  China,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Russian Federation,  Singapore,  Spain,  Taiwan,  Thailand, 

References & Publications (1)

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

Outcome

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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