Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy

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, 8th edition.

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

• Only one prior line of immunotherapy containing regimen is allowed inadvanced/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.

• Patients with actionable genetic alterations are allowed to be enrolled ifpatients received locally approved and available targeted agent in combinationwith immunotherapy in first-line advanced/metastatic setting.

• Enrollment of participants with primary resistance (best response beingradiological progression to prior immunochemotherapy) will be capped under 30%in the overall trial 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.

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

• Adequate organ function.

Key Exclusion Criteria:

• Known hypersensitivity to the study treatments, their metabolites or formulation ofexcipients including polysorbate 80 (see Docetaxel label).

• 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 14 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.

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

• Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula,tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscessor esophageal and gastric varices, or acute gastrointestinal bleeding. In addition,the participant must have undergone correction (or spontaneous healing) of theperforation/fistula and/or the underlying process causing the fistula/perforation.

• Participants with evidence of major coagulation disorders or other significant risksof hemorrhage.

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

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