BMS-986489 vs Atezolizumab for Small Cell Lung Cancer

Recruiting at 212 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bristol-Myers Squibb

Disqualifiers: Brain metastases, Lung diseases, Heart diseases, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Atezolizumab for small cell lung cancer?

Atezolizumab, when combined with chemotherapy, has been shown to improve overall survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone, as demonstrated in the IMpower133 trial. ^{1 2 3 4 5}

Is the treatment with BMS-986489 and Atezolizumab safe for humans?

Atezolizumab, used in various cancers including bladder and small cell lung cancer, has shown a favorable safety profile in clinical trials. Common side effects include rash and hypothyroidism (underactive thyroid), but it is generally well tolerated when combined with other treatments. ^{2 4 6 7 8}

How does the drug BMS-986489 differ from other treatments for small cell lung cancer?

BMS-986489 is unique because it combines atezolizumab, a drug that blocks a protein called PD-L1 to help the immune system fight cancer, with nivolumab and BMS-986012, potentially enhancing its effectiveness. This combination targets the immune system in a novel way compared to standard treatments for small cell lung cancer. ^{6 9 10 11 12}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with extensive-stage small cell lung cancer who are receiving their first line of therapy. Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they meet the necessary requirements.

Inclusion Criteria

I can do my normal activities with little or no help.

I have been diagnosed with extensive-stage small cell lung cancer.

I have a tumor outside the brain that can be measured by CT or MRI.

Exclusion Criteria

I have received treatments for advanced small cell lung cancer.

I have health issues like brain cancer spread, lung/heart disease, infections, other cancers, or nerve damage.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) or Atezolizumab in combination with Carboplatin plus Etoposide as first-line therapy

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• BMS-986489 (BMS-986012+Nivolumab) (Monoclonal Antibodies)

Trial Overview The study aims to compare a new treatment combination (BMS-986489, which includes Anti-fucosyl-GM1 and Nivolumab) with Carboplatin and Etoposide against an existing treatment (Atezolizumab) with the same chemotherapy drugs in patients with extensive-stage small cell lung cancer.

Participant Groups

Group I: Arm A Experimental Treatment 3 Interventions

Group II: Arm B Active Control 3 Interventions

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

The combination of atezolizumab, a PD-L1 inhibitor, with platinum-based chemotherapy significantly improves overall survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone.

This research suggests that this combination therapy could become a new first-line treatment option for patients suffering from this aggressive form of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study: Atezolizumab Improves Survival in SCLC. [2019]

In a study of 99 previously untreated patients with extensive disease small cell lung cancer (ED-SCLC), adding atezolizumab to the standard carboplatin and etoposide regimen significantly improved overall survival, extending it to 20.8 months compared to 12.1 months for those receiving carboplatin and etoposide alone.

While there was no significant difference in progression-free survival between the two treatment groups, certain subgroups (such as older patients, males, and those with better health status) showed particularly enhanced survival benefits from the addition of atezolizumab, indicating its potential for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab addition to platinum doublet: evaluating survival outcomes for patients with extensive disease small cell lung cancer. Kubo, S., Kobayashi, N., Matsumoto, H., et al.[2023]

In a phase 1 study involving 17 patients with relapsed or refractory small-cell lung cancer (SCLC), atezolizumab was generally well tolerated, with 64.7% experiencing any-grade treatment-related adverse events, the most common being fatigue.

Atezolizumab showed some antitumor activity, with a partial response in 5.9% of patients and a median overall survival of 5.9 months, suggesting potential benefits for patients with high T-effector gene signature and PD-L1 expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Chiang, AC., Sequist, LVD., Gilbert, J., et al.[2021]

Atezolizumab, combined with carboplatin and etoposide, significantly improves overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, based on data from the IMpower133 trial involving previously untreated patients.

The treatment regimen is generally well tolerated, with no new safety concerns identified, and it does not negatively impact patients' quality of life, making it a valuable first-line therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. Frampton, JE.[2021]

In a study of 158 patients with advanced non-small cell lung cancer, nivolumab showed a slightly higher objective response rate (22.5%) compared to atezolizumab (14.5%), but this difference was not statistically significant (p = 0.140).

Both treatments did not show significant differences in progression-free survival (PFS) and overall survival (OS), but atezolizumab had a more favorable safety profile, with fewer adverse events reported compared to nivolumab (49.3% vs. 76.4%, p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer. Alonso-García, M., Sánchez-Gastaldo, A., Muñoz-Fuentes, MA., et al.[2023]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Anti-PD-1/PD-L1 therapies (atezolizumab, pembrolizumab, nivolumab) significantly improve overall survival and progression-free survival in previously treated patients with advanced non-small-cell lung cancer (NSCLC) compared to docetaxel, based on a review of 14 trials involving 3786 subjects.

For patients with EGFR wild-type NSCLC, anti-PD-1/PD-L1 therapy offers better survival outcomes than EGFR-TKIs, while for EGFR mutant patients, it is less effective than EGFR-TKIs in terms of progression-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of anti-PD-1/PD-L1 therapy and its comparison with EGFR-TKIs for advanced non-small-cell lung cancer. Sheng, Z., Zhu, X., Sun, Y., et al.[2021]

Atezolizumab, a PD-L1 blocking antibody, shows higher rates of objective response, progression-free survival, and overall survival when used as a first-line therapy in chemotherapy-naïve patients with metastatic non-small cell lung cancer (NSCLC), compared to its use in later treatment lines.

The review included 15 ongoing studies, with 5 reporting results, indicating that atezolizumab is being explored in various treatment combinations and settings, suggesting its potential as a versatile first-line treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. Ryu, R., Ward, KE.[2023]

Atezolizumab is the first approved anti-PD-L1 inhibitor for treating squamous cell lung cancer (SqCLC) in patients who have experienced disease progression after initial therapies, highlighting its role in advanced stages of non-small cell lung cancer (NSCLC).

Current research is exploring atezolizumab's effectiveness in various treatment settings for SqCLC, indicating its potential for broader applications in future clinical scenarios, although specific target agents for this cancer subtype remain limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti PD-L1 antibody: is there a histologic-oriented efficacy? Focus on atezolizumab in squamous cell non-small cell lung cancer. Gemelli, M., Bidoli, P., Colonese, F., et al.[2022]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, an antibody targeting PD-L1, is effective as a second-line treatment for advanced non-small cell lung cancer (NSCLC), with case studies showing its use in patients with various genetic mutations, such as EGFR and ALK.

The treatment appears to provide clinical benefits even in patients with extensive metastases, suggesting that tumor mutational status and disease burden are important factors influencing the efficacy of atezolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Issues in the Use of Atezolizumab for Patients with Non-Small Cell Lung Cancer: Case Reports and Literature Review. Cobo, M., Rodríguez-Abreu, D., Pérez Parente, D., et al.[2021]

References

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

Study: Atezolizumab Improves Survival in SCLC. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Atezolizumab addition to platinum doublet: evaluating survival outcomes for patients with extensive disease small cell lung cancer. [2023]

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

Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Analysis of Nivolumab and Atezolizumab Efficacy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer. [2023]

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

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]

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

The efficacy of anti-PD-1/PD-L1 therapy and its comparison with EGFR-TKIs for advanced non-small-cell lung cancer. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]

10. Singapore pubmed.ncbi.nlm.nih.gov

Anti PD-L1 antibody: is there a histologic-oriented efficacy? Focus on atezolizumab in squamous cell non-small cell lung cancer. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Practical Issues in the Use of Atezolizumab for Patients with Non-Small Cell Lung Cancer: Case Reports and Literature Review. [2021]