Extensive-stage Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan) - Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic) - Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional - Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 - At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria - Adequate hematologic and end organ function - Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended - Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded - Symptomatic brain or other central nervous system (CNS) metastases - Paraneoplastic autoimmune syndrome requiring systemic treatment - History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan - Grade = 2 peripheral sensory neuropathy at study entry - Significant uncontrolled cardiovascular disease - Active, known or suspected autoimmune disease or inflammatory disorder Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0078 | Ballarat Central | Victoria |
| Australia | Local Institution - 0023 | Greenslopes | Queensland |
| Australia | Local Institution - 0001 | Malvern | Victoria |
| Australia | Local Institution - 0004 | Murdoch | Western Australia |
| Australia | Local Institution - 0003 | Westmead | New South Wales |
| Belgium | Grand Hôpital de Charleroi-Oncology & Hematology | Charleroi | |
| Belgium | Local Institution - 0034 | Gent | |
| Belgium | CHU de Liège | Liège | |
| Canada | Local Institution - 0064 | Brampton | Ontario |
| Canada | Local Institution - 0012 | Edmonton | Alberta |
| Greece | Local Institution - 0036 | Athens | |
| Greece | Local Institution - 0038 | Athens | |
| Greece | Local Institution - 0045 | Heraklion | Irakleío |
| Italy | Local Institution - 0030 | Peschiera del Garda | |
| Italy | Local Institution - 0031 | Pisa | |
| Italy | Local Institution - 0029 | Rozzano | |
| Japan | Local Institution - 0077 | Ina-machi | Saitama |
| Japan | Local Institution - 0070 | Osaka-Sayama City | Osaka |
| Japan | Local Institution - 0073 | Sendai | Miyagi |
| Japan | Local Institution - 0069 | Takatsuki | Osaka |
| Netherlands | Amsterdam UMC, locatie VUmc | Amsterdam | Noord-Holland |
| Netherlands | Rijnstate Ziekenhuis | Arnhem | |
| Netherlands | Umcg, Universitair Medisch Centrum Groningen | Groningen | |
| Netherlands | Local Institution - 0079 | Leiden | |
| Netherlands | Local Institution | Nijmegen | |
| Poland | Local Institution - 0049 | Gdansk | |
| Poland | Local Institution - 0048 | Lódz | |
| Romania | Local Institution - 0043 | Bucharest | |
| Romania | Local Institution - 0042 | Cluj | |
| Romania | Local Institution - 0041 | Craiova | |
| Spain | Local Institution - 0007 | Barcelona | Barcelona [Barcelona] |
| Spain | Local Institution - 0021 | Madrid | |
| Spain | Local Institution - 0005 | Majadahonda | |
| Spain | Local Institution - 0006 | Málaga | |
| United States | Local Institution - 0075 | Birmingham | Alabama |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution - 0060 | Cincinnati | Ohio |
| United States | Local Institution - 0067 | Cleveland | Ohio |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution - 0002 | Durham | North Carolina |
| United States | Local Institution - 0022 | Hackensack | New Jersey |
| United States | Local Institution | Lexington | Kentucky |
| United States | Local Institution - 0081 | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Belgium, Canada, Greece, Italy, Japan, Netherlands, Poland, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Up to 2 years and 100 days | ||
| Primary | Incidence of serious adverse events (SAEs) | Up to 2 years and 128 days | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 2 years and 128 days | ||
| Primary | Incidence of deaths | Up to 2 years and 128 days | ||
| Primary | Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Up to 2 years | ||
| Secondary | Progression-free survival rate (PFSR) | PFS by BICR based on RECIST v1.1 criteria | 6 and 12 months | |
| Secondary | PFS by investigator based on RECIST v1.1 criteria | Up to 2 years | ||
| Secondary | PFSR | PFS by investigator based on RECIST v1.1 criteria | 6 and 12 months | |
| Secondary | Objective response rate (ORR) based on RECIST v1.1 criteria | Up to 2 years | ||
| Secondary | Time to response (TTR) based on RECIST v1.1 criteria | Up to 2 years | ||
| Secondary | Duration of response (DOR) based on RECIST v1.1 criteria | Up to 2 years | ||
| Secondary | Overall survival (OS) | By arm | Up to 3 years | |
| Secondary | Overall survival rate (OSR) | By arm | Up to 3 years | |
| Secondary | Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs) | Up to 2 years |
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