Extensive-stage small-cell lung cancer
Conditions
Interventions
Stage 1
Arm 1 - Atezolizumab + Etoposide + Carboplatin (or cisplatin if carboplatin is not tolerated)
Arm 2 - BNT327 (Pumitamig) Dose 1 + Etoposide + Carboplatin (or cisplatin if carboplatin is not to
Sponsors
Dar Sara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system combined with Veterans Administration Lung Study Group [VALG]s two stage classification scheme For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan. -Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible. -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 (ECOG) performance status of 0 or 1. -Adequate hematologic and organ function as define in the protocol. NOTE: Other protocol defined Inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: -Have histologically or cytologically confirmed SCLC with combined histologies. -Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: -Within 2 weeks: small molecule agents with half-life of =7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies. -Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (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 the following central nervous system metastases: -Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm). -Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study. -Participants with known leptomeningeal metastases. -Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment. -Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. -Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol. -Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention. NOTE: Other protocol defined Exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) [Time Frame: Up to approximately 46 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| -Progression-free survival (PFS) [Time Frame: Up to approximately 46 months] -Objective response rate (ORR) [Time Frame: Up to approximately 46 months] -Duration of response (DOR) [Time Frame: Up to approximately 46 months] -PFS rate based on investigator's assessment [Time Frame: At 6, 12, and 18 months] -OS rate [Time Frame: At 6, 12, 18, and 24 months] -Occurrence of treatment-emergent adverse events (TEAEs) including Grade >=3, serious, and fatal TEAEs by relationship [Time Frame: From the first dose of study treatment to the 90-Day Follow-up Visit] -Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs) [Time Frame: From first to last dose of study treatment, i.e., up to 2 years] -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 score (Items 29 and 30) [Time Frame: Up to approximately 46 months] -Change from baseline in EORTC QLQ-C30 physical functioning [Time Frame: Up to approximately 46 months] -Change from baseline in coughing scale of the EORTC quality-of-life-Lung cancer 29 questionnaire (QLQ-LC29) [Time Frame: Up to approximately 46 months] -Change from baseline in shortness of breath scale of the EORTC QLQ-LC29[Time Frame: Up to approximately 46 months] -Change from baseline in coughed up blood item of the EORTC QLQ-LC29[Time Frame: Up to approximately 46 months] -Change from baseline in FACT-G overall bother item (FACT-GP5) [Time Frame: Up to approximately 46 months] | — |
Countries
Australia, China, France, Germany, Italy, Japan, Poland, South Korea, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed