Non-small Cell Lung Cancer
Conditions
Interventions
Substudy A (non-squamous NSCLC)
Phase 2
- BNT327 (pumitamig) Dose 1 + Carboplatin + Pemetrexed
- BNT327 (pumitamig) Dose 2 + Carboplatin + Pemetrexed
Phase 3
- BNT327 (pumitamig)+ Carboplatin + Pemet
Sponsors
Gocmez Huseyin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee 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, 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 metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). -Eastern Cooperative Oncology Group performance status of 0 or 1. -Adequate organ function. NOTE: Other protocol defined Inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: -Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component. -Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: -Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-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 of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. -Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. -Have a serious or non-healing wound, or bone (incompletely healed) fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. -Participants with significant risk of hemorrhage (per investigator clinical judgment). -Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2 (For substudies A (non-squamous NSCLC) and B (squamous NSCLC)) - Occurrence of treatment-emergent adverse events (TEAE) (including Grade >=3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs [Time Frame: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit] - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) [Time Frame: From the first dose of IMP to the 90-day Follow-Up Visit] - Objective response rate (ORR) [Time Frame: Up to approximately 2 years] - Best percentage change from baseline in tumor size [Time Frame: Up to approximately 2 years] Phase 3 (For substudies A and B) - Progression free survival (PFS) assessed by blinded independent central review (BICR) [Time Frame: Up to approximately 5 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 (For substudies A and B) - ORR - confirmed [Time Frame: Up to approximately 2 years] - Duration of Response (DOR) [Time Frame: Up to approximately 2 years] - Disease Control Rate (DCR) [Time Frame: Up to approximately 2 years] Phase 3 (For substudies A and B) - Overall survival (OS) [Time Frame: Up to approximately 5 years] - PFS assessed by investigator [Time Frame: Up to approximately 5 years] - ORR [Time Frame: Up to approximately 2 years] - PFS rate as assessed by BICR [Time Frame: At 6, 12, and 18 months] - PFS rate as assessed by investigator [Time Frame: At 6, 12, and 18 months] - OS rate [Time Frame: At 6, 12, 18, 24 months] - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-Core 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30) [Time Frame: Up to approximately 5 years] - Change from baseline in EORTC QLQ-C30 physical functioning [Time Frame: Up to approximately 5 years] - Change from baseline in coughing scale of the EORTC Lung Cancer-Specific QoL Questionnaire (QLC-LC29) [Time Frame: Up to approximately 5 years] - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 [Time Frame: Up to approximately 5 years] - Change from baseline in coughed up blood item of the EORTC QLQ-LC29 [Time Frame: Up to approximately 5 years] - Change from baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) fatigue domain score [Time Frame: Up to approximately 5 years] - Change from baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total pain domain score and domain score [Time Frame: Up to approximately 5 years] - Change from baseline in Functional Assessment of Cancer Therapy-General item 5 overall bother item (FACT-GP5). [Time Frame: Up to approximately 5 years] - Occurrence of TEAEs including Grade >=3, serious, and fatal TEAEs by relationship [Time Frame: From the first dose of IM | — |
Countries
Australia, Belgium, China, France, Germany, Italy, Japan, Poland, Romania, South Koria, Spain, Thailand, Turkey, UK, US
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed