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Active, not recruitingNCT05215340TROPION-Lung08Updated Sep 24, 2026

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

A Phase 3 interventional study of Datopotamab Deruxtecan and Pembrolizumab in Metastatic Non Small Cell Lung Cancer, sponsored by Daiichi Sankyo. Active, not recruiting at 234 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
740
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Read the detailed description

The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) by BICR or Overall Survival (OS) for participants with advanced or metastatic NSCLC with non-squamous histology without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.

Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.

02

Conditions studied

  • Metastatic Non Small Cell Lung Cancer

Keywords

  • Metastatic Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer
  • Datopotamab Deruxtecan (Dato-DXd)
  • Pembrolizumab
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 740 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.

  • Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
  • Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.

  • Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0):

    1. 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). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
    2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
    3. No known AGAs 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 in the first-line setting. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to randomization). Subjects whose tumors harbor KRAS mutations are eligible for the study.
  • Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
  • Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
  • Has an adequate treatment washout period before Cycle 1 Day 1.
  • Measurable disease based on local imaging assessment using RECIST Version 1.1.
  • Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
  • Has a life expectancy of at least 3 months.
  • Adequate bone marrow function within 7 days before randomization.

Exclusion criteria

Exclusion Criteria:

  • Has received prior systemic treatment for advanced or metastatic NSCLC.

  • Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:

    1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
    2. TROP2-targeted therapy.
    3. 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).
    4. Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
  • Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases and who are asymptomatic may participate provided they are radiologically stable.
  • Has received prior radiotherapy \< 4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.

  • History of another primary malignancy (beyond NSCLC) except for:

    1. 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.
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    3. Adequately treated carcinoma in situ without evidence of disease.
    4. Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.

  • Uncontrolled or significant cardiovascular disease, including:

    1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 ms regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
    2. Myocardial infarction within 6 months prior to randomization.
    3. Uncontrolled angina pectoris within 6 months prior to randomization.
    4. LVEF \<50% by ECHO or MUGA scan within 28 days before randomization.
    5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
    6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.

  • Clinically significant corneal disease.
  • Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) 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.
  • Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
  • Has known human immunodeficiency virus (HIV) infection that is not well controlled.
  • Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
  • Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • Had an allogeneic tissue/solid organ transplant.
  • Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
740 participants (actual)

Study arms

  • Experimental
    Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)

    Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.

    Drug: Datopotamab Deruxtecan · Drug: Pembrolizumab

  • Active comparator
    Pembrolizumb

    Participants will be randomized to receive 200 mg pembrolizumab.

    Drug: Pembrolizumab

Interventions

  • DrugDatopotamab Deruxtecan

    Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

    Also known as: Dato-DXd, DATROWAY®

  • DrugPembrolizumab

    Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

    Also known as: KEYTRUDA®

06

What researchers measure

Primary outcomes

  1. Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

    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.

    Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months

  2. Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Time frame: From randomization until date of death due to any cause, up to approximately 72 months

Secondary outcomes

  1. PFS Based on BICR in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    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 BICR per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

    Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months

  2. OS in Participants With Non-Squamous Histology, Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Time frame: From randomization until date of death due to any cause, up to approximately 72 months

  3. OS in All Randomized Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+) Participants

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Time frame: From randomization until date of death due to any cause, up to approximately 72 months

  4. OS in All Randomized Participants

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Time frame: From randomization until date of death due to any cause, up to approximately 72 months

  5. PFS Based on BICR in All Randomized Participants With Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+)

    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 BICR per RECIST Version 1.1.

    Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 46 months

  6. PFS Based on BICR in All Randomized Participants

    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 BICR per RECIST Version 1.1.

    Time frame: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  7. PFS Based on Investigator in Participants With Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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 Investigator per RECIST Version 1.1.

    Time frame: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  8. Progression-free Survival 2 (PFS2) in Participants With Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    PFS2 is defined as the time from date of randomization to the first documented disease progression on next-line therapy or death due to any cause, whichever occurs first.

    Time frame: From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 46 months

  9. ORR by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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 and by the Investigator per RECIST Version 1.1.

    Time frame: From randomization to first confirmed response, up to approximately 72 months

  10. Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Time frame: 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 72 months

  11. Time to Response by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Time frame: From randomization to date of first objective response (CR or PR), up to approximately 72 months

  12. Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, Non-Squamous TROP2 NMR+, All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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.

    Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 72 months

  13. Time to Deterioration in Participants with Non-Squamous Histology, Non-Squamous Trophoblast Cell Surface Protein 2 (TROP2) Normalized Membrane Ratio Positive (NMR+), All Randomized Participants, and All Randomized Participants That Are TROP2 NMR+

    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).

    Time frame: From randomization to first confirmed clinically meaningful symptom deterioration, up to 72 months

  14. Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants

    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.

    Time frame: Up to 72 months

Other outcomes

  1. Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA for Participants with Non-Squamous Histology, and Separately for All Randomized Participants

    The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.

    Time frame: Baseline and up to 72 months

07

Study locations

234 sites
  • Ironwood Cancer and Research Center
    Chandler, Arizona 85224, United States
  • UCLA HemOnc - Clinical Research Unit
    Los Angeles, California 90095, United States
  • Ridley-Tree Cancer Center
    Santa Barbara, California 93105, United States
  • PIH Health Whittier Hospital
    Whittier, California 90602, United States
  • The Oncology Institute of Hope and Innovation
    Whittier, California 90603, United States
  • Uch-Mhs D/B/A Memorial Health System
    Colorado Springs, Colorado 80909, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • American Oncology Partners of Maryland
    Bethesda, Maryland 20817, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Dana Farber Cancer Institute - Foxborough
    Foxborough, Massachusetts 02035, United States
  • DFCI - South Shore Hospital
    South Weymouth, Massachusetts 02190, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03766, United States
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
  • Regional Cancer Care Associates LLC
    Freehold, New Jersey 07728, United States
  • Cooperman Barnabas Medical Center
    New Brunswick, New Jersey 08901, United States
  • The Valley Hospital
    Paramus, New Jersey 07652, United States
  • Montefiore Medical Center
    The Bronx, New York 10461, United States
  • Arizona Oncology NAHOA
    Irving, Texas 75063, United States
  • Cancer Care Center of Brevard
    Irving, Texas 75063, United States
  • Illinois Cancer Specialists
    Irving, Texas 75063, United States
  • Maryland Oncology Hematology
    Irving, Texas 75063, United States
  • Southern Cancer Center
    Irving, Texas 75063, United States
  • Texas Oncology - Northeast Texas
    Irving, Texas 75063, United States
  • Texas Oncology Gulf Coast
    Irving, Texas 75063, United States
  • Texas Oncology McAllen
    Irving, Texas 75063, United States
  • University of Texas Health Science Center San Antonio
    San Antonio, Texas 78229, United States
  • Utah Cancer Specialists
    Salt Lake City, Utah 84106, United States
  • Providence Regional Cancer System
    Lacey, Washington 98503, United States
  • VA Puget Sound Health Care System - VAPSHCS
    Seattle, Washington 98108, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
    Buenos Aires, Argentina
  • Fundacion CENIT para la investigación en Neurociencias
    Ciudad Autonoma de Buenos Aire, 1125, Argentina
  • Hospital Privado de la Comunidad
    Mar del Plata, B7602CBM, Argentina
  • Centro de Investigación Pergamino S. A.
    Pergamino, 2700, Argentina
  • Instituto de Oncología de Rosario
    Rosario, S2000, Argentina
  • Sanatorio Parque
    Rosario, S2001, Argentina
  • Sanatorio Británico de Rosario
    Rosario, S2002, Argentina
  • CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
    San Juan, 5400, Argentina
  • Clinica Viedma SA
    Viedma, 8500, Argentina
  • Austin Hospital
    Heidelberg, Victoria 3084, Australia
  • Peninsula and South Eastern Haematology and Oncology Group
    Mount Waverley, Victoria 3149, Australia
  • Chris Obrien Lifehouse
    Camperdown, 2050, Australia
  • The Queen Elizabeth Hospital
    Woodville South, 5011, Australia
  • Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten
    Klagenfurt, Austria
  • Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf
    Vienna, 1090, Austria
  • Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
    Aalst, 9300, Belgium
  • Grand Hopital de Charleroi - Hopital Saint Joseph
    Charleroi, 6000, Belgium
  • Az Maria Middelares - Campus Maria Middelares
    Ghent, 9000, Belgium
  • AZ Nikolaas
    Sint-Niklaas, 9100, Belgium
  • Instituto de Pesquisas em Saúde - IPS
    Caxias do Sul, 95020-972, Brazil
  • Hospital Erasto Gaertner
    Curitiba, 81520-060, Brazil
  • Oncosite - Centro de Pesquisa Clinica Oncologia
    Ijuí, 98700-000, Brazil
  • Clínica de Neoplasias Litoral
    Itajaí, 88301-220, Brazil
  • UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks
    Pelotas, 96020-080, Brazil
  • Santa Casa de Misericordia de Porto Alegre
    Porto Alegre, 90050-170, Brazil
  • Instituto Nacional de Câncer - INCA
    Rio de Janeiro, 20231-050, Brazil
  • Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
    Santo André, 09060-870, Brazil
  • Instituto de Ensino e Pesquisas Sao Lucas
    São Paulo, 01236-030, Brazil
  • Instituto do Cancer Brasil - Unidade Taubate
    Taubaté, Brazil
  • McGill University Health Centre
    Montreal, H4A 3J2, Canada
  • Centro de Estudios Clínicos SAGA
    Santiago, Santiago Metropolitan 7500653, Chile
  • Oncovida
    Santiago, 7500000, Chile
  • Fundación Arturo Pérez López
    Santiago, 7500921, Chile
  • Orlandi Oncología
    Santiago, 7501010, Chile
  • Centro de Investigaciones Clinicas Vina Del Mar
    Viña del Mar, 254-0488, Chile
  • Guangxi Medical University Affiliated Tumor Hospital
    Nanning, Guangxi 530021, China
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
  • Jilin Cancer Hospital
    Changchun, Jilin 130012, China
  • Sichuan Cancer Hospital
    Chengdu, Sichuan 610049, China
  • Peking University Peoples Hospital
    Beijing, 100044, China
  • Peking University Cancer Hospital
    Beijing, 100142, China
  • Cangzhou People's Hospital
    Cangzhou, 610001, China
  • Hunan Cancer Hospital
    Changsha, 410013, China
  • Army Medical Center of PLA
    Chongqing, 400042, China
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    Guangzhou, 510095, China
  • Haikou People's Hospital
    Haikou, 570208, China
  • The First Affiliated Hospital of College of Medicine Zhejiang University
    Hanghzou, 310003, China
  • Harbin Medical University Cancer Hospital
    Harbin, 150081, China
  • Inner Mongolia Medical University- the Affiliated Hospital
    Hohhot, 10050, China
  • Jiamusi Tumor and Tuberculosis Hospital
    Jiamusi, 154007, China
  • Yunnan Cancer Hospital
    Kunming, 650118, China
  • Linyi Cancer Hospital
    Linyi, 276000, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, 330006, China
  • Jiangsu Province Hospital
    Nanjing, 210029, China
  • The Second People's Hospital of Neijiang
    Neijiang, 641000, China
  • Shanghai Pulmonary Hospital
    Shanghai, 200433, China
  • Fudan University Shanghai Cancer Center
    Shanghai Shi, 200032, China
  • The First Hospital of China Medical University
    Shenyang, 110001, China
  • Liaoning Cancer Hospital& Institute
    Shenyang, 110801, China
  • Tianjin Medical University General Hospital
    Tianjin, 300052, China
  • Xinjiang Tumor Hospital
    Ürümqi, 830000, China
  • Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
    Wuhan, 430022, China
  • Hubei Cancer Hospital
    Wuhan, 430079, China
  • The First Affiliate Hospitalof Xi'An Jiaotong University
    Xi'an, 710061, China
  • The First Affiliated Hospital Xiamen University
    Xiamen, 361001, China
  • Xiangyang Central Hospital- 5 Lumen Avenue
    Xiangyang, 441000, China
  • Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP)
    Avignon, 84000, France
  • Bordeaux University Hospital - Hopital Saint Andre
    Bordeaux, 33075, France
  • Institut Bergonie
    Bordeaux, 33076, France

Showing the first 100 of 234 sites across 28 countries.

08

References and documents

Publications

  • Levy BP, Felip E, Reck M, Yang JC, Cappuzzo F, Yoneshima Y, Zhou C, Rawat S, Xie J, Basak P, Xu L, Sands J. TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC. Future Oncol. 2023 Jul;19(21):1461-1472. doi: 10.2217/fon-2023-0230. Epub 2023 May 30. PubMed 37249038 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05215340
Lead sponsor
Daiichi Sankyo
Collaborators
AstraZeneca, Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Mar 4, 2022
Primary completion
Mar 4, 2030 (estimated)
Completion
Mar 4, 2032 (estimated)
Last update
Sep 24, 2026

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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