| Design |
A randomized, parallel-group, multisite, double-blind phase 3 safety and efficacy study to evaluate the addition of V940 (a mRNA-based INT) to adjuvant pembrolizumab in participants with resectable stage II-IIIB (N2) NSCLC who did not achieve a pCR after neoadjuvant pembrolizumab with platinum-doublet chemotherapy followed by surgery.
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| Intervention |
Experimental: Pembrolizumab + Intismeran autogene For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC] 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks). Interventions: Biological: Pembrolizumab Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Drug: Gemcitabine Drug: Paclitaxel Biological: Intismeran autogene
Active Comparator: Pembrolizumab + Placebo For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m^2, gemcitabine 1000 mg/m^2, paclitaxel 175 mg/m^2 or 200 mg/m^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to ~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks). Interventions: Biological: Pembrolizumab Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Drug: Gemcitabine Drug: Paclitaxel Other: Placebo
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| Key exclusion criteria |
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
- Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
- Received prior neoadjuvant therapy for their current NSCLC diagnosis
- Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
- Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
- Received prior treatment with a cancer vaccine
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
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