Recruiting
Phase 3
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Condition(s) studied
Extensive-stage Small-cell Lung Cancer
Investigational drug(s) / intervention(s)
PumitamigAtezolizumabEtoposideCarboplatin (or cisplatin if carboplatin is not tolerated)
Pumitamig: Intravenous infusion
Atezolizumab: Intravenous infusion
Etoposide: Intravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated): Intravenous infusion
Study summary
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).
Eligibility
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 defined in the protocol.
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; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
* 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 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 Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Overall survival (OS) — Up to approximately 46 months
OS defined as the time from randomization to death from any cause.
Trial sites (225)
| Facility | City | Region | Status |
| ACRC Arizona Clinical Research Center |
Tucson |
Arizona |
Recruiting |
| Clermont Oncology Center |
Clermont |
Florida |
Terminated |
| Cancer Care Centers of Brevard, Inc |
Palm Bay |
Florida |
Recruiting |
| Northside Hospital Atlanta |
Atlanta |
Georgia |
Recruiting |
| Illinois Cancer Specialists |
Niles |
Illinois |
Recruiting |
| Fort Wayne Medical Oncology and Hematology, Inc |
Fort Wayne |
Indiana |
Recruiting |
| McFarland Clinic |
Ames |
Iowa |
Recruiting |
| Helen G. Nassif Community Cancer Center |
Cedar Rapids |
Iowa |
Recruiting |
| Baptist Health Hardin Cancer Center |
Elizabethtown |
Kentucky |
Recruiting |
| LSU Health Baton Rouge - North Clinic |
Baton Rouge |
Louisiana |
Recruiting |
| Our Lady of the Lake Hospital, Inc. |
Baton Rouge |
Louisiana |
Recruiting |
| Frederick Health Hospital- James M Stockman Cancer Institute |
Frederick |
Maryland |
Recruiting |
| Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center |
Burlington |
Massachusetts |
Recruiting |
| Baptist Cancer Center |
Southaven |
Mississippi |
Recruiting |
| Washington University School of Medicine |
St Louis |
Missouri |
Recruiting |
| Nebraska Hematology-Oncology (NHO) |
Lincoln |
Nebraska |
Recruiting |
| Cornell University - NewYork-Presbyterian/Weill Cornell Medical Center |
New York |
New York |
Recruiting |
| White Plains Hospital |
White Plains |
New York |
Recruiting |
| Cleveland Clinic - Akron General Hematology & Oncology |
Akron |
Ohio |
Recruiting |
| Cleveland Clinic Mercy Hospital Cancer Center |
Canton |
Ohio |
Recruiting |
| The Christ Hospital Cancer Center |
Cincinnati |
Ohio |
Recruiting |
| University Hospitals Cleveland Medical Center |
Cleveland |
Ohio |
Recruiting |
| The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion |
Cleveland |
Ohio |
Recruiting |
| Cleveland Clinic Foundation |
Cleveland |
Ohio |
Recruiting |
| Kettering Medical Center |
Kettering |
Ohio |
Recruiting |
| Cleveland Clinic - Hillcrest Hospital |
Mayfield Heights |
Ohio |
Recruiting |
| St. Luke's Physician Group - St. Luke's Cancer Care Associates |
Fountain Hill |
Pennsylvania |
Recruiting |
| West Cancer Center & Research Institute |
Germantown |
Tennessee |
Recruiting |
| University of Tennessee Medical Center |
Knoxville |
Tennessee |
Recruiting |
| The University of Texas MD Anderson Cancer Center |
Houston |
Texas |
Recruiting |
| Millennium Research and Clinical Development, LLC |
Houston |
Texas |
Terminated |
| Texas Oncology Cancer Center |
Sugar Land |
Texas |
Recruiting |
| Virginia Cancer Specialists |
Fairfax |
Virginia |
Recruiting |
| Hematology Oncology Associates of Fredericksburg, Inc. |
Fredericksburg |
Virginia |
Recruiting |
| Virginia Commonwealth University School of Medicine |
Richmond |
Virginia |
Recruiting |
| Shenandoah Oncology |
Winchester |
Virginia |
Recruiting |
| Calvary Mater Newcastle |
Waratah |
New South Wales |
Recruiting |
| Cancer Care Wollongong Pty Limited |
Wollongong |
New South Wales |
Recruiting |
| Cairns Hospital |
Cairns |
Queensland |
Recruiting |
| Icon Cancer Centre Kurralta Park |
Kurralta Park |
South Australia |
Recruiting |
+ 185 more sites — see the full list on the official registry below.