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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05555732
Other study ID # DS1062-A-U303
Secondary ID 2022-500802-16-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 11, 2023
Est. completion date August 2027

Study information

Verified date May 2024
Source Daiichi Sankyo
Contact (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone 908-992-6400
Email CTRinfo@dsi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).


Description:

The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations. Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.


Recruitment information / eligibility

Status Recruiting
Enrollment 975
Est. completion date August 2027
Est. primary completion date August 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures. - Adults =18 at the time the Main ICF is signed. - Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing. - Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. - Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. - Has measurable disease based on local imaging assessment using RECIST v1.1. - Histologically documented NSCLC that meets all of the following criteria: - Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). - Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue. - No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening. - Has an adequate treatment washout period before Cycle 1 Day 1. - Is willing and able to participate in the collection of patient-reported outcomes (PRO) data. Exclusion Criteria: - Has received prior systemic treatment for advanced/metastatic NSCLC. - Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant (for NSCLC) setting: - Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I. - TROP2-targeted therapy. - Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137). - Any other immune checkpoint inhibitors. - Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance. - Has spinal cord compression or clinically active untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. - Uncontrolled or significant cardiovascular disease, including: - Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex. - Myocardial infarction within 6 months prior to randomization. - Uncontrolled angina pectoris within 6 months prior to randomization. - LVEF <50% by ECHO or MUGA scan within 28 days before randomization. - New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening. - Uncontrolled hypertension within 28 days before randomization. - Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. - History of another primary malignancy (beyond NSCLC) except for: - Malignancy treated with curative intent and with no known active disease =3 years before the first dose of study treatment and of low potential risk for recurrence. - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - Adequately treated carcinoma in situ without evidence of disease. - Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage =T2cN0M0 without biochemical recurrence or progression. - Has a history of severe hypersensitivity reactions to either the drugs or inactive ingredients of Dato-DXd, pembrolizumab, carboplatin, cisplatin or pemetrexed. - Has a history of severe hypersensitivity reactions to other monoclonal antibodies. - Has known human immunodeficiency virus (HIV) infection that is not well controlled. - Has active or uncontrolled hepatitis B or C infection. - Female who is pregnant or breastfeeding or intends to become pregnant. - Any other medical conditions, including cardiac disease or psychological disorders, and/or substance abuse. - Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. - Has active, known, or suspected autoimmune disease. - Has clinically significant corneal disease. - Has had an allogeneic tissue/solid organ transplantation. - Has received prior radiotherapy =4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Datopotamab Deruxtecan
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Pemetrexed
Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Carboplatin
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Cisplatin
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Locations

Country Name City State
Argentina Fundacion CENIT para la investigacion en Neurociencias Ciudad Autonoma de Buenos Aire
Argentina Hospital de La Comunidad Mar del Plata
Argentina Centro de Investigacion Pergamino Sa Pergamino
Argentina Instituto de Oncologia de Rosario Rosario
Argentina Sanatorio Parque Rosario
Argentina Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan San Juan
Argentina Centro de Investigaciones Clinicas. Clinica Viedma S.A. Viedma
Australia CRSA/ St Andrews Hospital Adelaide
Australia Flinders Medical Centre (Fmc) Bedford Park
Australia PSEHOG (Peninsula and South Eastern Haematology and Oncology Group) Frankston
Australia Southern Medical Day Care Centre Wollongong
Australia Princess Alexandra Hospital Woolloongabba
Austria Landeskrankenhaus Feldkirch Feldkirch
Austria Klinikum Klagenfurt Pulmologie Klagenfurt
Austria Arl Landsteiner Institut Fã¼R Lungenforschung Und Pneumologische Onkologie C/O Klinik Floridsdorf Vienna
Belgium Az Maria Middelares - Campus Maria Middelares Gent
Belgium Az Nikolaas Sint-Niklaas
Brazil Personal Oncologia de Precisao - Cenantron Belo Horizonte
Brazil Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs Caxias do Sul
Brazil Hospital Erasto Gaertner Curitiba
Brazil Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda Ijui
Brazil Clínica de Neoplasias Litoral Ltda ItajaA-
Brazil Clnica Lacks Pelotas
Brazil Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil Instituto Nacional de Ca'Ncer - Inca Rio de Janeiro
Brazil Centro de Estudos E Pesquisa de Hematologia E Oncologia - Cepho Santo Andre
Brazil Instituto de Ensino E Pesquisa Sao Lucas Sao Paulo
Brazil Instituto Do Cancer Brasil - Unidade Taubate Taubate
Canada CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus Quebec City
Chile ONCOVIDA Santiago
Chile Centro de Estudios Clinicos Saga Spa Santiago de Chile
Chile Centro de Investigaciones Clinicas Vina Del Mar ViAaa Del Mar
China Peking University Peoples Hospital Beijing
China Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute For Cancer Research Beijing Sheng
China Cangzhou Peoples Hospital Cangzhou
China First Affiliated Hospital of Medical College of Jilin University Changchun
China Jilin Cancer Hospital Changchun
China Hunan Cancer Hospital Changsha
China University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC Chengdu
China Chongqing University Cancer Hospital Chongqing
China Fujian Medical University - Union Hospital Foochow Christian Union Hospital Fuzhou
China Affiliated Cancer Hospital and Insititute of Guangzhou Medical University Guangzhou
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou
China The First Affiliated Hospital Sun Yat-Sen University Guangzhou
China Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou
China The First Affiliated Hospital of College of Medicine Zhejiang University Hangzhou
China Harbin Medical University Cancer Hospital Harbin
China An Hui Cancer Hospital Hefei
China Inner Mongolia Medical University- the Affiliated Hospital Hohhot
China Jiamusi Cancer Hospital Jiamusi
China Linyi Cancer Hospital Linyi
China The First Affiliated Hospital of Nanchang University Nanchang
China Zhongda Hospital, Southeast University Nanjing
China Fudan University Shanghai Cancer Center Shanghai
China Shanghai Chest Hospital Shanghai
China Liaoning Cancer Hospital & Institute Shenyang
China The First Affiliated Hosptial of Xinjiang Medical University Ürümqi
China Union Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan
China The First Affiliate Hospital of Xi'An Jiaotong University Xi'an
China Xiangyang Central Hospital Xianyang
China Henan Cancer Hospital Zhengzhou
France Chu de Bordeaux - Hopital Saint Andre Bordeaux
France Centre Hospitalier Universitaire, CHU, de Poitiers France
France Centre Leon Berard Lyon
France Aphm - Hopital Nord Marseille Cedex 20
France Chu de Montpellier Montpellier Cedex 5
France Chu de Nantes Nantes
France Hopital Prive Du Confluent Nantes
France Tenon Hospital Paris
France Hôpital Foch Suresnes
Germany Evangelische Lungenklinik Berlin Berlin
Germany Klinikum Chemnitz Chemnitz
Germany Universitaetsklinikum Essen Essen
Germany Klinikum Esslingen Gmbh Esslingen
Germany University Hospital Ma Nster Muenster
Germany Ludwig-Maximilians University Hospital of Munich Munich
Greece Sotiria General Hospital of Chest Diseases Athens
Greece University General Hospital of Heraklion Heraklion
Greece University Hospital of Ioannina Uhi Ioannina
Greece Metropolitan Hospital Neo Faliro
Greece Bioclinic Thessaloniki (Galinos Clinic) Thessalonki
Hong Kong Prince of Wales Hospital / The Chinese University of Hong Kong Hong Kong
Hong Kong Tuen Mun Hospital Hong Kong
Hong Kong Queen Mary Hospital Pok Fu Lam
Hungary National Koranyi Institute For Pulmonology Budapest
Hungary Veszprem Megyei Tudogyogyintezet Farkasgyepu Farkasgyepu
Hungary Bkmk Hospital KecskemAĊ t
Hungary Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly Szekesfehervar
Hungary Hetenyi G Korhaz, Onkologiai Kozpont Szolnok
Italy Istituto Di Candiolo Irccs Candiolo
Italy Azienda Ospedaliero - Universitaria San Luigi Gonzaga Orbassano
Italy Ospedale S. Maria Della Misericordia Udine
Italy Asst Sette Laghi Varese
Italy Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich Verona
Japan Kurume University Hospital Azuma
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyo-Ku
Japan Kyushu University Hospital Fukuoka
Japan Matsusaka Municipal Hospital Hataji
Japan Kansai Medical University Hospital Hirakata
Japan Iwakuni Clinical Center Iwakuni
Japan Kanazawa University Hospital Kanazawa-shi
Japan Juntendo University Hospital Kanemaru
Japan Yamanashi Prefectural Central Hospital Kofu
Japan The Cancer Institute Hospital of JFCR Koto
Japan NHO Shikoku Cancer Center Kozuki
Japan Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital Kumamoto
Japan University Hospital Kyoto Prefectual University of Medicine Kyoto
Japan Matsusaka City Hospital Matsusaka
Japan Niigata Cancer Center Hospital Niigata
Japan Hyogo Medical University Hospital Nishinomiya
Japan Kyushu Cancer Center Okamato
Japan Teine Keijinkai Hospital Sapporo-shi
Japan Sendai Kousei Hospital Sendai
Japan Dokkyo Medical University Hospital Shimotsuga-gun
Japan Osaka Toneyama Medical Center Toyonaka-shi
Japan Yamaguchi-Ube Medical Center Ube-shi
Japan Kanagawa Cancer Center Yokohama
Korea, Republic of Chungbuk National University Hospital Cheongjusi
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Samsung Medical Center Gangnam-Gu
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Gyeongsang National University Hospital Jinju-si Gyeongsangnam-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Yonsei University Health System - Severance Hospital Seoul
Netherlands Amphia Ziekenhuis Breda
Netherlands Leiden University Medical Center Leiden
Netherlands Jeroen Bosch Ziekenhuis Jbz s-Hertogenbosch
Poland Centrum Terapii Wspolczesnej Lodz
Poland Instytut Centrum Zdrowia Matki Polki (Iczmp) Lodz
Poland Med Polonia Sp. Z O.O. Poznan
Romania Institute of Oncology Prof. Dr. Ion Chiricuta Cluj- Napoca
Romania Centrul de Oncologie Sfantu Nectarie Craiova
Romania Onco Clinic Consult Sa Craiova
Romania Oncocenter Oncologie Clinica S.R.L Timisoara
Spain Hospital Clinic I Provincial de Barcelona Barcelona
Spain Vall Hebron University Hospital Barcelona
Spain Hospital Universitario Arnau de Vilanova Lleida
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital Regional Universitario Malaga Malaga
Spain CHUO Ourense
Spain Hosp Univ Virgen Macarena Sevilla
Spain Hospital Universitario y Politecnico de La Fe Valenica
Spain Hospital Universitario Miguel Servet Zaragoza
Switzerland Kantonsspital Baselland Liestal
Switzerland Kantonsspital St. Gallen St. Gallen
Switzerland Spital Sts Ag Thun
Taiwan China Medical University Hospital Hsia
Taiwan National Taiwan University Hospital Taipei
Thailand Faculty of Medicine Chulalongkorn University Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Siriraj Hospital Bangkok
Thailand Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital Chiang Mai
Thailand Prince of Songkla University PSU - Faculty of Medicine Hat Yai
Thailand Khon Kaen University - Faculty of Medicine-Srinagarind Hospital Mueang Nonthaburi
Turkey Baskent University Adana
United States Emory University - Winship Cancer Institute Wci Atlanta Georgia
United States Comprehensive Blood and Cancer Center Bakersfield California
United States American Oncology Partners of Maryland Bethesda Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute; Inv Drg Svc Pharm Boston Massachusetts
United States Dana Farber Cancer Institute At St. Elizabeth'S Medical Center Brighton Massachusetts
United States North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx Bronx New York
United States Ironwood Cancer and Research Centers Chandler Arizona
United States UCHealth Memorial Hospital Colorado Springs Colorado
United States Maryland Oncology Heamtology P.A. Columbia Maryland
United States Texas Oncology, P.A. Dallas Texas
United States Southern Cancer Center Pc Daphne Alabama
United States Astera Cancer Care East Brunswick New Jersey
United States Florida Cancer Specialists - South Fort Myers Florida
United States Dana Farber Brigham Cancer Center Foxboro Massachusetts
United States Regional Cancer Care Associates LLC Hackensack New Jersey
United States Cancer Specialist of North Florida Jacksonville Florida
United States Providence Regional Cancer System Lacey Washington
United States Dana Farber At Milford Regional Cancer Center Milford Massachusetts
United States North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park New Hyde Park New York
United States Hoag Memorial Hospital Prebyterian Newport Beach California
United States Illinois Cancer Specialists Niles Illinois
United States Cancer Care Centers of Brevard, Inc. Palm Bay Florida
United States North Shore Hematology Oncology Associates Patchogue New York
United States Woodlands Medical Specialists, Pa Pensacola Florida
United States North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists Port Jefferson Station New York
United States Arizona Oncology Associates, Pc - Nahoa Prescott Valley Arizona
United States Compassionate Cancer Care Medical Group Riverside California
United States Florida Cancer Specialists-North Saint Petersburg Florida
United States Utah Cancer Specialists IHO Corp Salt Lake City Utah
United States Ut Health San Antonio San Antonio Texas
United States Sansum Clinic Santa Barbara California
United States Dana Farber/Bwcc in Affiliation With South Shore Hospital South Weymouth Massachusetts
United States Texas Oncology-Tyler Tyler Texas

Sponsors (3)

Lead Sponsor Collaborator
Daiichi Sankyo AstraZeneca, Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival Based on Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Primary Overall Survival in Participants in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Overall Survival (OS) is defined as the time from randomization to death due to any cause. From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary Objective Response Rate by Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1. From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary Progression-free Survival by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1. From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary Objective Response Rate by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1. From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary Duration of Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1. From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 29 months
Secondary Time to Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1. From randomization to date of first objective response (CR or PR), up to approximately 29 months
Secondary Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1. From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary Progression-free Survival 2 in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary Time to Deterioration in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) Time to Deterioration (TTD) is defined as the time from randomization to first onset of a =10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent =10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a =10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13). From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAE) in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment. Up to 57 months
Secondary Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed. Baseline and up to 57 months
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