Immunotherapy + Chemotherapy for Lung Cancer
(CheckMate 816 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatment options for individuals with resectable non-small cell lung cancer (NSCLC) that can be surgically removed. Researchers compare the safety and effectiveness of a combination of nivolumab (an immunotherapy drug) and chemotherapy against chemotherapy alone, and they also examine nivolumab with ipilimumab (another immunotherapy drug). Individuals with early-stage NSCLC that can be operated on and whose lungs are healthy enough for surgery might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering access to potentially groundbreaking treatments.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using nivolumab with platinum-doublet chemotherapy is generally safe and well-tolerated. The FDA has already approved this combination for treating resectable non-small cell lung cancer (NSCLC). Studies indicate it significantly improves survival rates without causing unexpected side effects.
The combination of nivolumab with ipilimumab has also undergone extensive study. Results over five years suggest this treatment helps NSCLC patients live longer. However, some patients experienced immune-related side effects, such as lung inflammation, occurring in about 9% of cases. Despite these side effects, this combination has proven effective for many patients.
Overall, these treatments are being tested to ensure safety and effectiveness. While side effects can occur, healthcare teams usually manage and closely monitor them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for lung cancer because they combine powerful immunotherapies with traditional chemotherapy, aiming for a stronger attack on cancer cells. Unlike standard chemotherapy alone, Nivolumab and Ipilimumab are immunotherapy drugs that work by unleashing the immune system to better recognize and destroy cancer cells. The combination of Nivolumab with platinum doublet chemotherapy could enhance the effectiveness of existing chemo treatments, while the Nivolumab plus Ipilimumab duo offers a novel approach by focusing solely on boosting immune response. These combinations hold promise for improving outcomes by potentially extending survival and enhancing the quality of life for patients.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that combining nivolumab with platinum-based chemotherapy, one of the treatment arms in this trial, can lead to better results for patients with resectable non-small-cell lung cancer (NSCLC). Studies have found that this combination improves long-term outcomes compared to chemotherapy alone. Nivolumab helps the immune system attack cancer cells more effectively.
Another treatment arm in this trial involves the combination of nivolumab and ipilimumab. Evidence suggests this combination offers lasting survival benefits for NSCLC patients. In some studies, patients experienced significantly better survival rates compared to past data. Ipilimumab works with nivolumab to enhance the immune system's response against cancer cells.12678Who 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 people with early-stage IB-IIIA operable non-small cell lung cancer (NSCLC) who have good lung function and can handle surgery. They should be relatively healthy, which means having an ECOG Performance Status of 0-1. Those with advanced inoperable or metastatic disease, autoimmune diseases, or previous treatments targeting T cell pathways cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nivolumab plus ipilimumab, nivolumab plus platinum doublet chemotherapy, or platinum doublet chemotherapy alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Ipilimumab
- Nivolumab
- Paclitaxel
- Pemetrexed
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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
Ono Pharmaceutical Co. Ltd
Industry Sponsor
Shinji Takai
Ono Pharmaceutical Co. Ltd
Chief Medical Officer since 2023
MD from an unspecified institution
Gyo Sagara
Ono Pharmaceutical Co. Ltd
Chief Executive Officer since 2024
PhD in Pharmaceutical Sciences from Kyoto University