Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Key Inclusion Criteria:

• Have systemic treatment naive, histologically or cytologically confirmed diagnosisof Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) orStage IV NSCLC per the Union Internationale contre le Cancer/American JointCommittee on Cancer staging system, 9th edition.

• Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.Lesions treated after prior local treatment (radiotherapy, ablation, interventionalprocedures, etc.) are generally not considered as target lesions. If the lesion withprior local treatment is the only targeted lesion, evidence-based radiology must beprovided to demonstrate disease progression (the single bone metastasis or thesingle central nervous system metastasis should not be considered as a measurablelesion).

• Eastern Cooperative Oncology Group Performance Status of 0 or 1.

• Adequate organ function.

Key Exclusion Criteria:

• Have histologically or cytologically confirmed NSCLC with small-cell lung cancerhistologic or neuroendocrine component.

• Have received any of the following therapies or drugs within the noted timeintervals prior to study treatment:

• Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in eitherneo-adjuvant/adjuvant or locally advanced/metastatic setting.

• Participants who received prior treatment with anti-VEGF monoclonal antibody,or PD(L)-1/VEGF bispecific antibody

• Have received systemic corticosteroids (at a dosage greater than 10 mg/day ofprednisone or an equivalent dose of other corticosteroids) within 7 days priorto the initiation of study treatment. Note: local, intranasal, intraocular,intra-articular or inhaled corticosteroids, short-term use (<=7 days) ofcorticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) ortreatment of non-autoimmune conditions (e.g., delayed hypersensitivityreactions caused by exposure to allergens) are allowed.

• Have uncontrolled hypertension or poorly controlled diabetic conditions prior tostudy treatment.

• Have a serious or non-healing wound, or (incompletely healed) bone fracture. Thisincludes history (within 6 months prior to study entry) or risk of abdominalfistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominalabscess or esophageal and gastric varices. In addition, the participant must haveundergone correction (or spontaneous healing) of the perforation/fistula and/or theunderlying process causing fistula/perforation.

• Participants with significant risk of hemorrhage (per investigator clinicaljudgment).

• Have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.