BMS-986012 + Chemotherapy + Nivolumab for Small Cell Lung Cancer

Not currently recruiting at 96 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Pregnancy, Prior SCLC treatment, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding BMS-986012 (an experimental treatment) to a combination of carboplatin, etoposide, and nivolumab can safely extend the time people with extensive-stage small cell lung cancer (ES-SCLC) live without their cancer worsening. Participants will be divided into two groups: one will receive the standard treatment, while the other will also receive the new drug. Individuals newly diagnosed with ES-SCLC who have not received prior cancer treatment may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had prior chemotherapy, radiation, or biologic therapy for small cell lung cancer, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining BMS-986012 with nivolumab, carboplatin, and etoposide is generally safe and well-tolerated. Studies have found no unexpected safety problems with this treatment mix. Patients with relapsed or hard-to-treat small cell lung cancer (SCLC) have taken BMS-986012 with nivolumab safely, suggesting it might also be safe for those newly diagnosed.

Regarding the combination of carboplatin, etoposide, and nivolumab, studies have shown it does not introduce new safety concerns for patients with extensive-stage small cell lung cancer (ES-SCLC). This combination helps patients live longer without adding new risks.

Overall, evidence suggests that both treatment options in the study should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential of combining a novel antibody, BMS-986012, with established chemotherapy and immunotherapy options. Unlike the current standard treatments for small cell lung cancer, which typically involve chemotherapy regimens like carboplatin and etoposide with or without immune checkpoint inhibitors like nivolumab, BMS-986012 specifically targets a unique protein found on cancer cells. This targeted approach could enhance the immune system's ability to attack the cancer more effectively. The addition of BMS-986012 might improve outcomes by potentially increasing the precision and effectiveness of the treatment, offering new hope for patients with this aggressive cancer type.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

In this trial, participants will be assigned to one of two treatment arms. Arm A will receive a combination of Carboplatin, Etoposide, Nivolumab, and BMS-986012. Research has shown that adding BMS-986012 to this regimen appears promising for treating extensive-stage small cell lung cancer (ES-SCLC), with early results suggesting a slight improvement in progression-free survival (PFS) and potential for better overall survival (OS). Arm B will receive Carboplatin, Etoposide, and Nivolumab without BMS-986012. This combination has already demonstrated better PFS and OS compared to older treatments for ES-SCLC, with no new safety issues identified. Overall, these findings suggest potential benefits for people with ES-SCLC. ^{1 2 3 4 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed extensive-stage small cell lung cancer (ES-SCLC). Participants must have good blood and organ function, at least one measurable tumor, and be able to use contraception if needed. They should not have had prior treatments for SCLC or certain health conditions like uncontrolled heart disease or active autoimmune diseases.

Inclusion Criteria

If you want to take part in the PET tracer sub-study, you need to provide a recent tumor biopsy from any location where the cancer is found.

My lung cancer is at an advanced stage and cannot be treated with just radiation.

My blood and organs are functioning well.

Exclusion Criteria

I have an autoimmune or inflammatory condition.

I have symptoms from cancer spread to my brain or CNS.

I have not had chemotherapy, radiation, or biologic therapy for small cell lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986012 in combination with carboplatin, etoposide, and nivolumab as first-line therapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986012
• Carboplatin
• Etoposide
• Nivolumab

Trial Overview The study tests the safety and effectiveness of BMS-986012 combined with carboplatin, etoposide, and nivolumab in improving survival without cancer progression. It's compared against a combination of just carboplatin, etoposide, and nivolumab as first-line therapy in ES-SCLC patients.

How Is the Trial Designed?

Group I: Arm B: Carboplatin + Etoposide + Nivolumab Experimental Treatment 3 Interventions

Group II: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 Experimental Treatment 4 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a phase II trial involving 55 patients with limited-stage small cell lung cancer, the combination of paclitaxel, carboplatin, and etoposide showed promising efficacy, with 37.1% achieving a complete response and 51.4% a partial response.

The treatment was associated with moderate toxicity, primarily hematologic, but no life-threatening complications were reported, indicating that the regimen is tolerable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel, carboplatin, and oral etoposide: a phase II trial in limited-stage small cell lung cancer. Gatzemeier, U., Jagos, U., Kaukel, E., et al.[2015]

In a study of 4408 patients with small cell lung cancer (SCLC), cisplatin did not show a survival advantage over carboplatin for either extensive-stage (ES-SCLC) or limited-stage (LS-SCLC) disease, indicating that both treatments are similarly effective.

Carboplatin's favorable toxicity profile makes it a suitable option for both LS-SCLC and ES-SCLC, potentially allowing for better integration with new treatment strategies in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Carboplatin With Cisplatin in Small Cell Lung Cancer in US Veterans. Azar, I., Yazdanpanah, O., Jang, H., et al.[2023]

In the CASPIAN study involving 805 patients with extensive-stage small-cell lung cancer (ES-SCLC), the combination of durvalumab and platinum-etoposide significantly improved overall survival compared to platinum-etoposide alone, with a median survival of 12.9 months versus 10.5 months.

However, adding tremelimumab to durvalumab and platinum-etoposide did not provide a significant survival benefit, indicating that durvalumab plus platinum-etoposide should be considered the new standard of care for first-line treatment of ES-SCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Goldman, JW., Dvorkin, M., Chen, Y., et al.[2021]

Combination treatments using platinum compounds and etoposide show median survival rates of 7 to 10 months for extensive-stage and 15 to 20 months for limited-stage small cell lung cancer, indicating their effectiveness in improving patient outcomes.

Adding paclitaxel to platinum/etoposide regimens has shown promising results in early studies, with good activity and manageable toxicity, and ongoing phase III trials aim to clarify its role in enhancing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current role and future prospects of paclitaxel in the treatment of small cell lung cancer. Hainsworth, JD., Greco, FA.[2015]

A systematic review of 36 clinical trials found that chemotherapy regimens including cisplatin (CDDP) and/or etoposide (VP16) significantly improve survival rates in patients with small cell lung cancer (SCLC), with combined hazard ratios indicating a clear survival benefit for both drugs.

Specifically, regimens containing etoposide alone or in combination with cisplatin showed strong evidence of effectiveness, with hazard ratios of 0.72 for VP16 and 0.57 for combinations, suggesting these treatments should be prioritized in SCLC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the role of etoposide and cisplatin in the chemotherapy of small cell lung cancer with methodology assessment and meta-analysis. Mascaux, C., Paesmans, M., Berghmans, T., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04702880

NCT04702880 | A Study of BMS-986012 in Combination ... The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)02462-5/fulltext

1664TiP A phase II randomized study of BMS-986012, an ... Here we describe a phase II, randomized, open-label global study assessing the safety and efficacy of BMS-986012 combined with carboplatin-etoposide and NIVO as ...

3. onclive.com onclive.com/view/frontline-bms-986012-plus-nivolumab-chemotherapy-shows-promise-in-es-sclc

Frontline BMS-986012 Plus Nivolumab/Chemotherapy ... BMS-986012 plus nivolumab and chemotherapy provided a modest PFS benefit but signals of OS improvement in extensive-stage small cell lung cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9579497/

BMS-986012, an Anti–Fucosyl-GM1 Monoclonal Antibody ... BMS-986012 is currently being explored in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in extensive-stage SCLC (NCT04702880).

5. bmsstudyconnect.com bmsstudyconnect.com/ca/en/clinical-trials/NCT06646276.html

study connect - BMS Clinical Trials A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to ...

6. clinicaltrials.eu clinicaltrials.eu/trial/study-of-bms-986012-with-carboplatin-etoposide-and-nivolumab-for-first-line-treatment-in-patients-with-extensive-stage-small-cell-lung-cancer/

Study of BMS-986012, carboplatin, etoposide and ... This clinical trial investigates the efficacy of BMS-986012 in combination with carboplatin, etoposide, and nivolumab for first-line ...