Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
NCT05555732 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1170
Last updated 2026-03-25
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).
Conditions
Interventions
- DRUG
-
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
- DRUG
-
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
- DRUG
-
Pemetrexed
Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
- DRUG
-
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
- DRUG
-
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-11
- Primary Completion
- 2029-05-11
- Completion
- 2029-05-11
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- Czechia
- France
- Germany
- Greece
- Hong Kong
- Hungary
- Italy
- Japan
- Mexico
- Netherlands
- Poland
- Portugal
- Romania
- South Korea
- Spain
- Switzerland
- Taiwan
- Thailand
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
NCT05687266 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
NCT04940325 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
NCT06564844 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
NCT04656652 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Datopotamab Deruxtecan (Dato-DXd) for Non-Small Cell Lung Cancer (NSCLC) Patients With Active Brain Metastases
NCT06676917 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
NCT05775289 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
NCT06899126 ·Status: RECRUITING ·Phase: PHASE3
-
Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC
NCT04153734 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
NCT06822543 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
NCT02578680 ·Status: COMPLETED ·Phase: PHASE3
-
Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer
NCT03847519 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT04619797 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer
NCT04740021 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)
NCT03829319 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
NCT06008093 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
NCT05777603 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT02367781 ·Status: COMPLETED ·Phase: PHASE3
-
Vactosertib in Combination with Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
NCT04515979 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT02507375 ·Status: COMPLETED ·Phase: PHASE1
-
Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
NCT02129699 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
NCT03515837 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
NCT02409342 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer
NCT01357395 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy
NCT05796089 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
NCT03455556 ·Status: TERMINATED ·Phase: PHASE1