Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Sponsor: Daiichi Sankyo + AstraZeneca, Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants
Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive
Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Overall Survival in All Randomized Participants
Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Overall Survival in All Randomized Participants who are TROP2 NMR positive
Time frame: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Secondary Endpoints
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive
Progression-free Survival by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive
Eligibility Criteria
Key Inclusion Criteria: 1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. 2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old). 3. Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study. 4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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