Immunotherapy + Chemotherapy for Lung Cancer

(CheckMate 9LA Trial)

No longer recruiting at 263 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: EGFR inhibitors, ALK inhibitors

Disqualifiers: EGFR mutations, ALK translocations, untreated CNS metastases

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 23 months

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

Your PD-L1 levels must be tested by a central lab before you can join the study.

Your disease can be measured using CT or MRI scans according to specific guidelines.

My lung cancer is at stage IV or recurrent and I haven't had cancer drugs before.

Exclusion Criteria

My brain metastases are treated, and I've been stable for 2 weeks.

My cancer does not have EGFR mutations treatable with targeted therapy.

I do not have ALK translocations sensitive to current treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab and Ipilimumab combined with chemotherapy or chemotherapy alone

23 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

23 months

Every 3 months

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?

Group I: Module A Experimental Treatment 6 Interventions

Chemotherapy/Biologics combined

Group II: Module B Active Control 4 Interventions

Chemotherapy Combination

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8607256/

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 ...

2. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(21)00255-5/fulltext

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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9516617/

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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525730424000846

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%.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.e21717

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.

6. opdivohcp.com opdivohcp.com/efficacy/nsclc/opdivo-yervoy-chemo

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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9204732/

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02259621

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, ...

9. opdivohcp.com opdivohcp.com/safety/nsclc/opdivo-yervoy-chemo

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 ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0169500223000107

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.