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Tests treatment safety and results for Extensive-stage Small-cell Lung Cancer
Official title Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
ClinicalTrials.gov ID: NCT06712355
What this study is testing
What is Pumitamig?
Pumitamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive-stage small-cell lung cancer.
Also referred to as BNT327, BMS-986545.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system...
- Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated...
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic and organ function as defined in the protocol.
You likely can't join if
- 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; radiation outside the thoracic cavity including whole brain radiation. Of note...
- Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies...
- Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD[L]-1)/VEGF...
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7...
See the full eligibility 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...
- 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...
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, treatment procedures, etc.) are generally not considered as target...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic and organ function as defined in the protocol.
- 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; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed...
- Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based...
- 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...
- 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...
- 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...
- 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 Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Clermont, Florida, United States
- Palm Bay, Florida, United States
- Atlanta, Georgia, United States
- Niles, Illinois, United States
- Fort Wayne, Indiana, United States
- Ames, Iowa, United States
- Cedar Rapids, Iowa, United States
- Elizabethtown, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Frederick, Maryland, United States
- Burlington, Massachusetts, United States
- Southaven, Mississippi, United States
- St Louis, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- White Plains, New York, United States
- Akron, Ohio, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
+ 167 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Clermont, Florida, United States; Palm Bay, Florida, United States; Atlanta, Georgia, United States; Niles, Illinois, United States; Fort Wayne, Indiana, United States and 181 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.