Atezolizumab + Cabozantinib for Non-Small Cell Lung Cancer

(CONTACT-01 Trial)

Recruiting at 182 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Antibiotics, Antivirals, Anticoagulants, Immunosuppressants

Disqualifiers: CNS metastases, Severe infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Up to approximately 24 months

366 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, atezolizumab (an immunotherapy) and cabozantinib, to determine if they are more effective than the standard drug, docetaxel, for treating advanced non-small cell lung cancer (NSCLC). The trial aims to discover if this combination can halt cancer growth in patients unresponsive to treatments like chemotherapy and certain immunotherapies. Patients with NSCLC, whose disease has spread and who have not benefited from chemotherapy and immunotherapy, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of atezolizumab and cabozantinib is generally well-tolerated. Atezolizumab is a type of immunotherapy, while cabozantinib blocks certain proteins that help cancer grow. In studies, most side effects were manageable and similar to those seen in other cancer treatments. Common issues included tiredness, diarrhea, and loss of appetite, usually mild to moderate.

Serious side effects were less common, but some patients experienced more severe reactions, such as liver problems or high blood pressure. Side effects can vary from person to person. Overall, the safety of this combination aligns with typical expectations for cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Atezolizumab combined with Cabozantinib for non-small cell lung cancer because it brings a fresh approach to treatment. Unlike the standard care options like chemotherapy, this combination leverages the power of immunotherapy and targeted therapy. Atezolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, while Cabozantinib targets specific pathways that promote tumor growth and spread. This dual action not only enhances the body's natural defenses but also directly interferes with cancer progression, offering a promising alternative to traditional treatments.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that combining atezolizumab and cabozantinib, which participants in this trial may receive, can help treat advanced non-small cell lung cancer (NSCLC). Studies suggest that cabozantinib boosts the immune system by targeting proteins that usually weaken it. This combination has shown promising results, with patients living longer without disease progression and more patients experiencing tumor shrinkage in earlier trials. Initial findings indicate that this treatment may extend life, especially for those who have tried other treatments. Another treatment arm in this trial involves participants receiving docetaxel as an active comparator. ^{3 4 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab in combination with cabozantinib or docetaxel monotherapy in 21-day cycles

Up to approximately 24 months

1 visit every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 24 months

Long-term follow-up

Participants are monitored for overall survival and adverse events

Up to 41 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Cabozantinib
• Docetaxel

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.

How Is the Trial Designed?

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.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02166

CONTACT-01: A Randomized Phase III Trial of ... To evaluate the efficacy and safety of atezolizumab plus cabozantinib versus docetaxel in patients with metastatic non–small cell lung cancer ( ...

2. ir.exelixis.com ir.exelixis.com/news-releases/news-release-details/exelixis-provides-update-phase-3-contact-01-trial-evaluating

Exelixis Provides Update on Phase 3 CONTACT-01 Trial ... Exelixis Provides Update on Phase 3 CONTACT-01 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Metastatic Non-Small Cell Lung ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394869/

Analysis of the Efficacy and Safety of Cabozantinib ... Comparable survival advantages were observed in extensive-stage small cell lung cancer in the IMpower133 trial, and improved PFS and ORR were ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT308569

Results from cohort 7 of the COSMIC-021 study. Cabozantinib (C) may augment response to ICI by inhibiting kinases implicated in suppressing immune cell responses and has shown encouraging clinical activity ...

5. jtocrr.org jtocrr.org/article/S2666-3643(24)00036-5/fulltext

Results From the Phase 1b COSMIC-021 Study Cabozantinib plus atezolizumab demonstrated modest clinical activity and manageable toxicity in advanced NSCLC after progression on prior ICI. Keywords.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38552197/

CONTACT-01: A Randomized Phase III Trial ... CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05859217

NCT05859217 | A Study of Combining Cabozantinib and ... In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic ...