Triple Therapy for Small Cell Lung Cancer

Recruiting at 7 trial locations

Overseen by Salma Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jyoti Malhotra

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of three drugs for patients with small cell lung cancer that has returned after earlier treatment. The drugs work together by stopping cancer growth and boosting the immune system to fight the cancer.

Research Team

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults over 18 with recurrent small cell lung cancer (SCLC) who have seen their disease progress after platinum-based chemotherapy. They must have tried a PD-1/PD-L1 therapy if entering Phase II, be in good health otherwise, and women of childbearing age must test negative for pregnancy and agree to use two forms of contraception.

Inclusion Criteria

I have recovered from major side effects of previous treatments, except for hair loss, mild fatigue, skin color changes, or stable hormone issues.

I am a man who agrees to use two forms of birth control during and for 31 weeks after treatment.

I am a woman who can have children and have a recent negative pregnancy test.

Exclusion Criteria

I have never received CTLA-4 targeted therapy.

I haven't taken part in any drug trials in the last 28 days, except for COVID-19 treatment or vaccination.

I have or had lung inflammation that needed steroids, except for radiation-caused cases.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Plinabulin (Other)

Trial Overview The study tests Nivolumab, Ipilimumab, and Plinabulin in patients with SCLC that came back after first-line treatment. It's an open-label trial meaning everyone knows what treatment they're getting. The first phase checks the right dose while the second phase looks at how well these drugs work together.

Participant Groups

Group I: Phase II: nivolumab, ipilimumab, and plinabulin Experimental Treatment 3 Interventions

On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (MTD from Phase I). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur .

Group II: Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulin Experimental Treatment 3 Interventions

On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (escalating cohorts, IV). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur. Plinabulin escalation is as follows: Level -1 : 13.5mg/m\^2 Level 1 (start) : 20mg/m\^2 Level 2 : 30mg/m\^2

Who Is Running the Clinical Trial?

Jyoti Malhotra

Lead Sponsor

Trials

1

Recruited

40+

Salma Sabbour

Lead Sponsor

Trials

1

Recruited

40+

Bristol-Myers Squibb

Industry 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

Rutgers Cancer Institute of New Jersey

Collaborator

Trials

72

Recruited

22,200+

BeyondSpring Pharmaceuticals Inc.

Industry Sponsor

Trials

9

Recruited

1,200+