Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L N… (NCT05555732) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
United States1,170 participantsStarted 2023-01-11
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
✓. 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.
✓. 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 assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study.
Exclusion criteria
✕. Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.
✕. Has received prior systemic treatment for advanced/metastatic NSCLC.
✕. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):
What they're measuring
1
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants
Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
2
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive
Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
3
Overall Survival in All Randomized Participants
Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
4
Overall Survival in All Randomized Participants who are TROP2 NMR positive
Timeframe: From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
✕. TROP2-targeted therapy
✕. Any anti-PD-1, anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
✕. Any other ICIs Subjects 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 or metastatic disease.
✕. Has received a live vaccine within 30 days prior to the first dose of study treatment.