Extensive-stage Small Cell Lung CancerPhase 2NCT04702880
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing BMS-986012, Carboplatin and Etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Bristol-Myers Squibb at 39 sites in 11 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- BMS-986012, Carboplatin and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 39 sitesin 11 countries
- Study dates
- 17 Mar 2021to 28 Nov 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Significant uncontrolled cardiovascular disease
- Active, known or suspected autoimmune disease or inflammatory disorder
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
39 sites in 11 countries.
39 sites in 11 countries
United States8 sites
Local Institution - 0075
Birmingham, Alabama, 35249
Local Institution - 0060
Cincinnati, Ohio, 45267
Local Institution
Cincinnati, Ohio, 45267
Local Institution - 0067
Cleveland, Ohio, 44106-1716
Local Institution
Dallas, Texas, 75390
Local Institution - 0002
Durham, North Carolina, 27710
Local Institution - 0022
Hackensack, New Jersey, 07601
Local Institution - 0081
Nashville, Tennessee, 37203
Australia4 sites
Local Institution - 0023
Greenslopes, Queensland, 4120
Local Institution - 0001
Malvern, Victoria, 3144
Local Institution - 0004
Murdoch, Western Australia, 6150
Local Institution - 0003
Westmead, New South Wales, 2145
Japan4 sites
Local Institution - 0077
Ina-machi, Saitama, 362-0806
Local Institution - 0070
Ōsaka-sayama, Osaka, 589-8511
Local Institution - 0073
Sendai, Miyagi, 980-0873
Local Institution - 0069
Takatsuki, Osaka, 5698686
Spain4 sites
Local Institution - 0007
Barcelona, Barcelona [Barcelona], 08035
Local Institution - 0021
Madrid, 28041
Local Institution - 0005
Majadahonda, 28222
Local Institution - 0006
Málaga, 29010
Belgium3 sites
Local Institution - 0051
Charleroi, Hainaut, 6060
Local Institution - 0034
Ghent, 9000
Local Institution - 0050
Liège, 4000
Greece3 sites
Local Institution - 0036
Athens, 11527
Local Institution - 0038
Athens, 185 47
Local Institution - 0045
Heraklion, Irakleío, 715 00
Italy3 sites
Local Institution - 0030
Peschiera del Garda, 37019
Local Institution - 0031
Pisa, 56124
Local Institution - 0029
Rozzano, 20089
Netherlands3 sites
Local Institution - 0039
Amsterdam, North Holland, 1081 HV
Local Institution - 0066
Arnhem, 6815 AD
Local Institution - 0040
Groningen, 9700RB
Romania3 sites
Local Institution - 0043
Bucharest, 022328
Local Institution - 0042
Cluj-Napoca, 400015
Local Institution - 0041
Craiova, 200542
Canada2 sites
Local Institution - 0064
Brampton, Ontario, L6R 3J7
Local Institution - 0012
Edmonton, Alberta, T6G 1Z2
Poland2 sites
Local Institution - 0049
Gdansk, 80-214
Local Institution - 0048
Lodz, 93-338
About this study
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).
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- BMS-986012, Carboplatin, Etoposide, Nivolumab
- Keywords
- BMS-986012, Carboplatin, Etoposide, Extensive-stage small cell lung cancer, Fucosyl, Nivolumab, Targeted SCLC therapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986012Biological
Also called Fucosyl-GM1 Antibody
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
EtoposideDrug
Specified dose on specified days
NivolumabBiological
Also called BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 | Experimental | Not described Receives: Biological: BMS-986012; Drug: Carboplatin; Drug: Etoposide; Biological: Nivolumab |
| Arm B: Carboplatin + Etoposide + Nivolumab | Experimental | Not described Receives: Drug: Carboplatin; Drug: Etoposide; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)
Number of Participants With Serious Adverse Events
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)
Number of Participants With Adverse Events Leading to Discontinuation
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)
Number of Participants Who Died
Number of participants who died due to any cause.
Measured: From first dose to primary cutoff date (Up to approximately 43 months)
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method.
Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Measured: From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)
Secondary outcomes (8)
Progression Free Survival Rate (PFSR) at 6 and 12 Months
PFSR is defined as the percentage of participants progression free at 6 and 12 months. PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Blinded Independent Central Review (BICR) and by investigator, or death from any cause.
Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Measured: 6 and 12 months
Progression Free Survival (PFS) Per Investigator
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Investigator or death from any cause. Estimates are based on Kaplan-Meier product-limit method.
Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Measured: From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months)
Objective Response Rate (ORR)
ORR per Blinded Independent Central Review (BICR) and per investigator is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Measured: From randomization to the date of first documented response (Up to approximately 56 months)
Duration of Response (DoR)
DoR per Blinded Independent Central Review and per investigator is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Measured: From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months)
Time to Response (TTR)
TTR per Blinded Independent Central Review (BICR) and per investigator is defined for participants who had a confirmed CR or PR as the time from the date of randomization to date of first documented CR or PR per RECIST v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Measured: From randomization to the date of first documented CR or PR (Up to approximately 56 months)
Overall Survival (OS)
OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.
Measured: From randomization to the date of death due to any cause (Up to approximately 56 months)
Overall Survival Rate (OSR) at 12 and 24 Months
OSR is defined as the percentage of participants surviving at 12 and 24 months. OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.
Measured: 12 and 24 months
Number of Participants With Anti-Nivolumab Antibody (ADA)
ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. Baseline ADA Positive: A participant with baseline ADA-positive sample.
Measured: From baseline up to approximately 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start17 Mar 2021
- Primary completion22 May 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702880
- Sponsor's protocol ID
- CA001-050
- Other IDs
- 2020-001863-10, U1111-1250-4427
- Status last verified
- May 2026
- First submitted
- 7 Jan 2021
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Publications
Chu Q, Leighl NB, Surmont V, van Herpen C, Sibille A, Markman B, Clarke S, Juergens RA, Rivera MA, Andelkovic V, Rudin CM, Snow S, Kim DW, Sanatani M, Lin H, Sanghavi K, Tannenbaum-Dvir S, Basciano P, Lathers D, Urbanska K, Kollia G, He C, DiPiero A, Liu Y, Ready N. BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study. JTO Clin Res Rep. 2022 Aug 27;3(11):100400. doi: 10.1016/j.jtocrr.2022.100400. eCollection 2022 Nov.
PubMed 36275912