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

Recruiting at 92 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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986012 combined with three existing treatments to help newly diagnosed patients with severe lung cancer. The goal is to see if this combination can stop the cancer from growing better than the current treatments alone.

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.

What data supports the effectiveness of the drug combination BMS-986012, Carboplatin, Etoposide, and Nivolumab for treating small cell lung cancer?

Research shows that combinations of platinum compounds like carboplatin and etoposide are effective in treating small cell lung cancer, with median survival times of 7 to 10 months for extensive-stage and 15 to 20 months for limited-stage disease. Additionally, carboplatin is preferred for its lower toxicity compared to cisplatin, and the combination with etoposide has shown promising results in various studies. ^{1 2 3 4 5}

What safety information is available for the combination of BMS-986012, Carboplatin, Etoposide, and Nivolumab in treating small cell lung cancer?

Carboplatin and Etoposide have been studied in combination for small cell lung cancer, showing moderate toxicity with common side effects like low blood cell counts (neutropenia, anemia, thrombocytopenia) and mild nausea. Nivolumab, used in other treatments, is generally well-tolerated but can cause immune-related side effects. No life-threatening complications were reported in the studies reviewed. ^{6 7 8 9 10}

What makes the drug BMS-986012 + Chemotherapy + Nivolumab unique for small cell lung cancer?

This treatment combines BMS-986012, a novel drug, with chemotherapy and Nivolumab (an immune therapy) to potentially enhance the body's immune response against small cell lung cancer, which is different from standard chemotherapy regimens that typically do not include immune therapies. ^{1 11 12 13 14}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

VP16-213 in combined modality treatment of small cell carcinoma of the lung. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Carboplatin With Cisplatin in Small Cell Lung Cancer in US Veterans. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of cisplatin/etoposide and concurrent radiotherapy followed by paclitaxel/carboplatin consolidation for limited small-cell lung cancer: Southwest Oncology Group 9713. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Quality versus quantity of life in the treatment of patients with advanced small-cell lung cancer? A randomized phase III comparison of weekly carboplatin and teniposide versus cisplatin, adriamycin, etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine. Swiss Group for Clinical Cancer Research (SAKK). [2020]

5. United States pubmed.ncbi.nlm.nih.gov

The current role and future prospects of paclitaxel in the treatment of small cell lung cancer. [2015]

6. England pubmed.ncbi.nlm.nih.gov

A phase I and pharmacokinetic study of intraperitoneal carboplatin and etoposide. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel, carboplatin, and oral etoposide: a phase II trial in limited-stage small cell lung cancer. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Experiences with VP-16 in combination with cyclophosphamide or adriamycin in the anaplastic, predominantly small cell bronchogenic carcinoma]. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Phase I study of a carboplatin-etoposide combination in advanced thoracic cancer. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

[Phase I/II study of a combination regimen composed of cisplatin, carboplatin and etoposide against small cell lung cancer]. [2013]

11. China pubmed.ncbi.nlm.nih.gov

[Teniposide and cisplatin compared with etoposide and cisplatin for treatment of small cell lung cancer]. [2015]

12. England 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. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. [2015]

14. Ireland 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. [2019]