Atezolizumab + Cabozantinib for Non-Small Cell Lung Cancer

(CONTACT-01 Trial)

Recruiting at 155 trial locations

Overseen By Reference Study ID Number: GO41892 www.roche.com/about_roche/roche_worldwide.htm

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with metastatic Non-Small Cell Lung Cancer (NSCLC) who have already been treated with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibodies. Participants must be in good physical condition, not have HIV or hepatitis, and agree to use contraception. They cannot join if they've had certain other treatments recently, have severe organ problems, uncontrolled infections or diseases that could interfere with the study.

Inclusion Criteria

I have recovered from previous cancer treatment side effects, or they are stable and not serious.

My cancer's PD-L1 status is known or can be tested.

I agree to not have sex or use birth control, and not donate sperm.

Exclusion Criteria

I do not need frequent procedures for fluid buildup in my chest or abdomen.

I have ongoing nerve issues affecting my senses or movement.

I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Cabozantinib (Small Molecule Kinase Inhibitor)
• Docetaxel (Taxane)

Trial Overview The study compares Atezolizumab combined with Cabozantinib against Docetaxel alone in patients whose NSCLC has worsened after previous treatments. It's a Phase III trial where participants are randomly assigned to either treatment group to assess effectiveness and safety.

Participant Groups

Group I: Atezolizumab + Cabozantinib Experimental Treatment 2 Interventions

Participants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle.

Group II: Docetaxel Active Control 1 Intervention

Participants received docetaxel on Day 1 of each 21-day cycle.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD