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

Recruiting at 214 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

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

461 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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