Immunotherapy + Chemotherapy for Lung Cancer
(CheckMate 9LA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining the immunotherapy drugs Nivolumab and Ipilimumab with chemotherapy drugs such as Carboplatin, Cisplatin, Paclitaxel, and Pemetrexed is more effective in treating stage IV non-small cell lung cancer (NSCLC) than chemotherapy alone. It involves two groups: one receiving both immunotherapy and chemotherapy, and the other receiving only chemotherapy. Suitable candidates have been diagnosed with stage IV NSCLC and have not yet started cancer treatment. This study could enhance first-line treatment options for those with advanced lung cancer. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants an opportunity to contribute to advancing treatment options.
Do I need to stop my current medications to join 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 shows that combining nivolumab and ipilimumab with chemotherapy is generally well-tolerated by patients with non-small cell lung cancer (NSCLC). Studies have found that this treatment can cause side effects, but they are usually manageable.
One study identified tiredness, nausea, and loss of appetite as the most common side effects. Serious side effects were less common but could include inflammation in different parts of the body. Despite this, the combination has been used and studied in various settings, and many patients find its safety profile acceptable.
Testing this treatment in a later phase of clinical trials suggests strong evidence already exists about its safety. While all treatments have potential risks, the data so far supports that this combination can be used safely for treating NSCLC.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for lung cancer, which typically involves chemotherapy alone, the investigational treatments in this trial combine immunotherapy with chemotherapy. Researchers are excited about this approach because it harnesses the power of the immune system to fight cancer cells more effectively. The immunotherapy drugs, Ipilimumab and Nivolumab, work by targeting and blocking proteins that prevent immune cells from attacking cancer, potentially leading to a more robust and sustained response. This combination has the potential to improve outcomes beyond what traditional chemotherapy regimens can achieve on their own.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that using nivolumab and ipilimumab with chemotherapy, as participants may receive in Module A of this trial, can extend the lives of people with advanced non-small cell lung cancer (NSCLC). In previous studies, patients receiving this combination lived longer overall than those who received only chemotherapy. Specifically, after six years, 15% of patients still responded well to the combination treatment. Module B of this trial involves carboplatin and paclitaxel, which has shown promising results, with some patients having a 54% chance of surviving at least one year. This evidence suggests that both treatment options in this trial can improve outcomes for people with stage IV NSCLC.678910
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 Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC) who haven't had cancer treatment before. They should have measurable disease, be in good physical condition (ECOG ≤1), and not have certain gene mutations like EGFR or ALK that respond to other drugs. People with untreated brain metastases are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab and Ipilimumab combined with chemotherapy or chemotherapy alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Ipilimumab
- Nivolumab
- Paclitaxel
- Pemetrexed
Trial Overview
The study is testing if a combination of the immune therapies Nivolumab and Ipilimumab with chemotherapy works better than chemotherapy alone as the first line of attack against advanced NSCLC. Participants will receive either the drug combo or just chemo to compare effectiveness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Chemotherapy/Biologics combined
Chemotherapy Combination
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
Citations
First‐line nab‐paclitaxel plus carboplatin for patients with ...
These real‐world data support the effectiveness and safety of nab‐P/C as first‐line treatment for patients with advanced NSCLC independent of ...
Efficacy and safety of carboplatin with nab-paclitaxel ...
Our study showed that overall survival was longer with carboplatin plus nab-paclitaxel than with docetaxel, suggesting that carboplatin plus nab-paclitaxel can ...
Paclitaxel/carboplatin in the treatment of non-small-cell ...
Results with this regimen have shown substantial promise, and 1-year survival rates as high as 54% have been reported. Full doses of both agents have been ...
Carboplatin, Weekly Paclitaxel and Pembrolizumab in ...
Carboplatin, weekly Paclitaxel (CwP) and Pembrolizumab is feasible in patients aged ≥70 with stage IV NSCLC and PD-L1 < 50%.
Real-world outcomes of pembrolizumab plus carboplatin ...
13.9% of nab-pac and 7.9% of pac patients had grade 3/4 toxicities (p = 0.16). At data cut-off, 18 nab-pac (15.7%) and 30 pac (21.6%) patients were deceased.
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) + Chemo ...
Neoadjuvant treatment with platinum-doublet chemotherapy for non-small cell lung cancer followed by single-agent OPDIVO as adjuvant treatment after surgery.
A Phase 2 Clinical Trial of Combination Nivolumab ...
In addition, the safety and adverse event profile was described for combination of nivolumab, ipilimumab, and paclitaxel in untreated, metastatic NSCLC.
Study Details | NCT02259621 | Neoadjuvant Nivolumab, or ...
The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, ...
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) + Chemo ...
View the selected safety profile for OPDIVO® (nivolumab) + YERVOY® (ipilimumab) + chemo in r/m NSCLC. Please see Indications and Important Safety ...
Long-term comparative efficacy and safety of nivolumab ...
This study indicates trends towards long-term benefit with NIVO + IPI compared with other IO-based combinations, with manageable toxicities.
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