A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

New Trial Tests Promising Combination Therapy for Extensive-Stage Small Cell Lung Cancer

NCT: NCT06646276 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Bristol-Myers Squibb · Started: 2025-02-25 · Est. Completion: 2031-09-05

Plain English Summary

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ 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 (TIGOS). is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Extensive-Stage Small Cell Lung Cancer. This trial tests a new drug combination (BMS-986489 with nivolumab, carboplatin, and etoposide) against a standard treatment (atezolizumab with carboplatin and etoposide) for extensive-stage small cell lung cancer. It is for adults diagnosed with extensive-stage small cell lung cancer who have not received prior treatment for this stage of the disease. Participation involves receiving one of the two treatment regimens, with regular medical check-ups and monitoring for side effects. Standard chemotherapy and immunotherapy are current options, but this trial explores a potentially more effective new combination. The trial aims to enroll 530 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a confirmed diagnosis of extensive-stage small cell lung cancer. Individuals who are healthy enough to perform daily activities with minimal assistance. Patients must have at least one measurable tumor that can be seen on scans (not in the brain or nervous system). People who have already received treatment for extensive-stage small cell lung cancer, or have certain health conditions like symptomatic brain metastases, significant lung or heart disease, or autoimmune disorders, cannot participate. This trial is studying Extensive-Stage Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome, Overall Survival, measures how long patients live after starting treatment, indicating the new combination's potential to extend life. The specific primary outcome measures are: Overall Survival (OS) (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for improved first-line treatments for extensive-stage small cell lung cancer, a disease with limited effective options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Extensive-Stage Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial represents a significant investment by Bristol-Myers Squibb in a competitive oncology market, aiming to establish a new standard of care with a high probability of approval if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 530 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, how often you will need to visit the clinic, and what side effects to expect. Participation involves receiving study treatments, undergoing regular blood tests, scans, and physical exams to monitor your health and the cancer's response. Be prepared for potential travel to study sites for appointments and treatments. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria

* Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
* Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
* Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system

Exclusion Criteria

* Participants have already received certain types of treatment for extensive stage small cell lung cancer
* Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy
* Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06646276?

NCT06646276 is a Phase 3 INTERVENTIONAL study titled "A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ 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 (TIGOS).." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 530 participants.

What conditions does NCT06646276 study?

This trial investigates treatments for Extensive-Stage Small Cell Lung Cancer. The primary condition under study is Extensive-Stage Small Cell Lung Cancer.

What treatments are being tested in NCT06646276?

The interventions being studied include: BMS-986489 (BMS-986012+Nivolumab) (BIOLOGICAL), Atezolizumab (BIOLOGICAL), Carboplatin (DRUG), Etoposide (DRUG). Specified dose on specified days

What does Phase 3 mean for NCT06646276?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06646276?

This trial is currently "Recruiting." It started on 2025-02-25. The estimated completion date is 2031-09-05.

Who is sponsoring NCT06646276?

NCT06646276 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06646276?

The trial aims to enroll 530 participants. The trial is currently recruiting and accepting new participants.

How is NCT06646276 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06646276?

The primary outcome measures are: Overall Survival (OS) (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06646276 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Hot Springs, Arkansas; Fort Myers, Florida; Orange City, Florida and 16 more sites (United States).

Where can I find official information about NCT06646276?

The official record for NCT06646276 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06646276. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06646276 testing in simple terms?

This trial tests a new drug combination (BMS-986489 with nivolumab, carboplatin, and etoposide) against a standard treatment (atezolizumab with carboplatin and etoposide) for extensive-stage small cell lung cancer. It is for adults diagnosed with extensive-stage small cell lung cancer who have not received prior treatment for this stage of the disease.

Why is this trial significant?

This trial addresses a critical need for improved first-line treatments for extensive-stage small cell lung cancer, a disease with limited effective options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06646276?

Common side effects may include fatigue, nausea, vomiting, hair loss, and changes in blood counts. More serious risks can include severe allergic reactions, infections, and potential damage to nerves or organs. Specific risks related to the study drugs, such as immune-related side effects, will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06646276?

Ask your doctor about the specific drugs being tested, how often you will need to visit the clinic, and what side effects to expect. Participation involves receiving study treatments, undergoing regular blood tests, scans, and physical exams to monitor your health and the cancer's response. Be prepared for potential travel to study sites for appointments and treatments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06646276 signal from an investment perspective?

This trial represents a significant investment by Bristol-Myers Squibb in a competitive oncology market, aiming to establish a new standard of care with a high probability of approval if successful. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves receiving one of the two treatment regimens, with regular medical check-ups and monitoring for side effects. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Extensive-Stage Small Cell Lung Cancer Trials

View all Extensive-Stage Small Cell Lung Cancer clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.