Chemotherapy + Nivolumab for Early Stage Non-Small Cell Lung Cancer

Not currently recruiting at 243 trial locations

Overseen By BMS Study Connect Contact Center http://www.bmsstudyconnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Anti-cancer, Immunotherapy

Disqualifiers: Autoimmune disease, Hepatitis, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding nivolumab, a type of immunotherapy, to standard chemotherapy can help people with early-stage non-small cell lung cancer live longer without cancer recurrence. It compares two groups: one receives standard chemotherapy with a placebo (inactive substance), and the other receives chemotherapy with nivolumab. The trial seeks participants with early-stage lung cancer that can be surgically removed, who have not undergone previous cancer treatments, and who do not have brain metastases (cancer spread to the brain). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does require that you have not had any prior treatment for non-small cell lung cancer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining nivolumab with platinum-based chemotherapy is safe for people with non-small cell lung cancer. Studies indicate that patients tolerate this combination well. Evidence suggests that nivolumab, when used with treatments like carboplatin and paclitaxel, does not cause unexpected side effects.

The most common side effects resemble those from standard chemotherapy, such as tiredness, nausea, and a decrease in blood cell counts. Severe side effects, however, are rare. Overall, this treatment is considered manageable and safe for patients with this type of lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining chemotherapy with nivolumab for early-stage non-small cell lung cancer because it represents a new approach by integrating immunotherapy with traditional chemotherapy. Unlike standard treatments, such as surgery or chemotherapy alone, this combination uses nivolumab, an immune checkpoint inhibitor, to help the body's immune system recognize and attack cancer cells more effectively. This dual-action approach has the potential to enhance treatment effectiveness and improve patient outcomes by not only targeting the cancer cells directly but also empowering the immune system to combat the disease more vigorously.

What evidence suggests that this trial's treatments could be effective for early stage non-small cell lung cancer?

In this trial, participants will receive either a combination of nivolumab with platinum-based doublet chemotherapy (such as cisplatin or carboplatin) or a placebo with platinum-based doublet chemotherapy. Research has shown that nivolumab, when combined with chemotherapy drugs like cisplatin or carboplatin, can help treat non-small cell lung cancer (NSCLC). Studies have found that nivolumab extends patient survival compared to treatments like docetaxel. It boosts the immune system to better fight cancer cells. Combining it with chemotherapy aims to enhance its effectiveness, especially in early-stage cancer. Previous patients treated with this combination showed promising results, suggesting it could extend the time without cancer events. ^{2 3 5 6 7}

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 early stage Non-Small Cell Lung Cancer that can be surgically removed. They should not have had previous cancer treatments, no brain metastasis, and must be in good physical condition (ECOG ≤ 1). Patients who've received certain immunotherapies or have autoimmune diseases, hepatitis B/C, or HIV cannot participate.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer has not spread to my brain.

My lung cancer is at an early stage and can be surgically removed.

Exclusion Criteria

You have a current or suspected autoimmune disease.

I have received cancer treatments such as chemotherapy, immunotherapy, targeted therapy, or radiation for NSCLC.

You have tested positive for hepatitis B, hepatitis C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant chemotherapy plus either nivolumab or placebo

12 weeks

Regular visits for chemotherapy administration

Surgical Resection

Participants undergo surgical resection of the tumor

1 week

1 visit for surgery

Adjuvant Treatment

Participants receive adjuvant treatment with nivolumab or placebo

24 months

Regular visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

44 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cisplatin
• Docetaxel
• Nivolumab
• Paclitaxel
• Pemetrexed

Trial Overview The study tests if adding the drug Nivolumab to standard chemotherapy before and after surgery can extend the time patients remain free from cancer events compared to just chemotherapy with a placebo. Participants are randomly assigned to receive either Nivolumab or placebo.

How Is the Trial Designed?

Group I: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Experimental Treatment 6 Interventions

Group II: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Placebo Group 6 Interventions

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/PMC4872256/

Pemetrexed for advanced stage nonsquamous non-small ... Four phase II studies investigated the combination of pemetrexed with cisplatin or carboplatin for nonsquamous NSCLC first-line treatment [Zinner et al. 2005].

2. opdivohcp.com opdivohcp.com/dosing/nsclc

NSCLC Dosing Schedules | OPDIVO® (nivolumab) Histology-based chemo; SQ patients: carboplatin AUC 6 + paclitaxel 200 mg/m2 q3w; NSQ patients: carboplatin AUC 5 or 6 or cisplatin 75 mg/m2 + pemetrexed 500 mg ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1613493

First-Line Nivolumab in Stage IV or Recurrent Non–Small- ... Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non–small-cell lung cancer ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05500092

NCT05500092 | An Open Label, Randomized Study of ... To compare the complete pathological response rate after 3 cycles of neoadjuvant nivolumab and platinum-based doublet chemotherapy vs. the same regimen with the ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)36539-1/fulltext

a four arms phase Ib study This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430718/

Feasibility Study of Nivolumab in Combination with ... The findings suggest that nivolumab combined with CCRT is a safe and promising treatment option for patients with previously untreated unresectable locally ...

7. hemonc.org hemonc.org/wiki/Non-small_cell_lung_cancer,_nonsquamous

Non-small cell lung cancer, nonsquamous Randomized phase III study of docetaxel plus cisplatin versus pemetrexed plus cisplatin as first-line treatment of nonsquamous non-small-cell lung cancer: a ...