Cabozantinib + Nivolumab for Lung Cancer

Recruiting at 717 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether cabozantinib alone or with nivolumab is better than other treatments for patients with a type of lung cancer called non-squamous non-small cell lung cancer. Cabozantinib stops cancer cells from growing, while nivolumab helps the immune system fight the cancer. The goal is to see if these treatments can help patients live longer without their cancer getting worse.

Research Team

Joel W Neal

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with non-squamous non-small cell lung cancer (NSCLC) who've had one round of platinum-based chemo and checkpoint inhibitor immunotherapy. They must have manageable side effects from past treatments, no major organ issues, can swallow pills, and have no severe heart conditions or untreated viral infections. Pregnant individuals or those planning to conceive are excluded.

Inclusion Criteria

I have previously received treatments like anti-VEGF, ipilimumab, or experimental drugs.

My doctor has documented the chemotherapy plan if I'm assigned to Arm C of the study.

My kidney function, measured by creatinine levels or clearance, is within the required range.

Exclusion Criteria

I do not have any heart, blood vessel, or clotting disorders.

I don't have any health issues that would make it unsafe for me to take cabozantinib and nivolumab.

I haven't taken certain medications recently.

Treatment Details

Interventions

• Cabozantinib S-malate (Tyrosine Kinase Inhibitor)
• Nab-paclitaxel (Cytotoxic Agent)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The study tests if cabozantinib alone or combined with nivolumab is more effective than standard chemotherapy in NSCLC treatment. Cabozantinib blocks enzymes needed for tumor growth; nivolumab boosts the immune system's cancer fight. Standard chemo drugs kill or stop cancer cells from growing.

Participant Groups

Group I: Step 2, Arm Z (cabozantinib S-malate, nivolumab) Experimental Treatment 5 Interventions

Patients in Step 2, Arm Z receive cabozantinib S-malate PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group II: Step 1, Arm B (cabozantinib S-malate, nivolumab) Experimental Treatment 5 Interventions

Patients in Step 1, Arm B receive cabozantinib S-malate PO QD and nivolumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group III: Step 1, Arm A (cabozantinib S-malate) Experimental Treatment 4 Interventions

Patients in Step 1, Arm A receive cabozantinib S-malate PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may continue to receive therapy after investigator-assessed RECIST 1.1 defined progression, including stable clinical and performance status and have potential for continued clinical benefit. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Group IV: Step 1, Arm C (standard chemotherapy) Active Control 8 Interventions

Patients in Step 1, Arm C receive ramucirumab IV over 30-60 minutes and docetaxel IV over 1 hour on day 1, or docetaxel IV over 1 hour on days 1 and 8, or gemcitabine hydrochloride IV on days 1 and 8, or paclitaxel IV over 3 hours on day 1, or nab-paclitaxel IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity and at the discretion of the treating physician. Patients also undergo ECHO as clinically indicated, CT throughout the trial, and collection of blood on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+