Brief Summary
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells choice for standard-of-care and type of NSCLC.
Intervention / Treatment
- Drug: BNT327
- Drug: Pembrolizumab
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Paclitaxel
Inclusion Criteria:
- Have histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of Stage IIIB or IIIC (who are not amenable to curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas system, 8th edition without actionable EGFR mutation or anaplastica term used to describe abnormal cancer cells that grow uncontrollably in the body and have little or no resemblence to regular cells lymphomacancers of the lymphatic system kinase rearrangement.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasiswhen the cancer has spread to other parts of the body, also known as mets or the single central nervous system metastasis should not be considered as a measurable lesion).
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Adequate organ function.