Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)
Sponsor: BioNTech SE + BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Part 1 - Occurrence of dose limiting toxicities (DLTs)
Time frame: Up to 21 days after first dose of investigational medicinal product (IMP)
Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interest
Time frame: From initiation of the first dose of IMP to the 90-day Follow-Up visit
Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events
Time frame: From initiation of the first dose of IMP until the 90-day Safety Follow-up visit
Part 1 and Part 2 - Objective response rate
Time frame: Up to approximately 2 years
Secondary Endpoints
Part 1 and Part 2 - Duration of Response
Part 1 and Part 2- Progression-free Survival
Part 1 and Part 2 - Depth of Response
Eligibility Criteria
Key Inclusion Criteria: * Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 9th edition. * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study. * Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months. * Historical PD-L1 results must be available. * Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in comb…
Read full criteria on CT.gov →✦ Analyst Commentary
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