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

Key Inclusion Criteria:

• Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that hasdocumented radiographic progression on one or after one prior line of systemictreatment (programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1] inhibitorand platinum-based chemotherapy concomitantly) in advanced/metastatic setting perthe American Joint Committee on Cancer staging system, 9th edition.

• Participants must have received minimum two cycles of immunotherapy infirst-line treatment to be eligible to this study.

• Only one prior line of immunotherapy containing regimen is allowed in anadvanced/metastatic setting. If participant had received adjuvant immunotherapythe 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 theyreceived locally approved and available targeted agent in combination withimmunotherapy in first-line advanced/metastatic setting.

• Enrollment of participants with primary resistance (best response beingradiological progression to prior immunochemotherapy) will be kept below 30% inthe overall study population.

• Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.Tumor lesions situated in a previously irradiated area are considered measurable ifprogression has been documented after irradiation. Historical images within 28 daysof the screening visit may be accepted as a screening image if deemed acceptable inthe opinion of the investigator.

• Participants must provide tumor tissue samples obtained ≤18 months prior toenrollment. For the additional cohort in Part 2, both baseline (freshly obtained)and on-treatment tumor biopsy samples are required.

• Eastern cooperative oncology group performance status of 0 or 1.

• Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

• Have a known or suspected hypersensitivity to the study treatments, theirmetabolites or formulation of excipients including polysorbate 80 (see Docetaxellabel).

• Participants who received prior treatment with anti-vascular endothelial growthfactor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody ordocetaxel as monotherapy or in combination with other agents.

• Have received more than one prior lines of therapies in advanced/metastatic setting.

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

• Participants who have received prior radiotherapy may be enrolled if they have noacute toxicity related to this therapy.

• Have uncontrolled hypertension or poorly controlled diabetic conditions within 7days prior to the first dose of study 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, or acute gastrointestinal bleeding. Inaddition, the participant must have undergone correction (or spontaneous healing) ofthe perforation/fistula and/or the underlying process causing thefistula/perforation.

• Participants with significant risk of hemorrhage as defined in the protocol.

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

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.