Sitravatinib + Nivolumab for Advanced Non-Small Cell Lung Cancer

(SAPPHIRE Trial)

Recruiting in Palo Alto (17 mi)

+579 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mirati Therapeutics Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced non-squamous NSCLC who've had disease progression after platinum-based chemo and checkpoint inhibitor therapy. They should have tried one or two treatments before, but not more, and can't have uncontrolled brain metastases or certain genetic mutations.

Inclusion Criteria

I have been treated with both PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

My cancer progressed after treatment with a checkpoint inhibitor.

I've had 1 or 2 treatments for my advanced illness.

Exclusion Criteria

I've had cancer treatment after immunotherapy, not including maintenance chemo.

My tumor is positive for EGFR, ROS1, ALK mutations, or ALK fusions.

I have brain metastases that are not currently under control.

Treatment Details

Interventions

• Docetaxel (Cytotoxic agent)
• Nivolumab (Checkpoint Inhibitor)
• Sitravatinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests sitravatinib combined with nivolumab against docetaxel in patients whose lung cancer worsened despite previous therapies. It aims to see if the new combination is more effective than the standard treatment of docetaxel alone.

Participant Groups

Group I: Nivolumab and Sitravatinib Experimental Treatment 2 Interventions

Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.

Group II: Docetaxel Active Control 1 Intervention

Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.

Docetaxel is already approved in Canada, Japan for the following indications:

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

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