48 Participants Needed

Atezolizumab + Cobimetinib for Lung Cancer

Recruiting at 17 trial locations
TW
RA
Overseen ByRaid Aljumaily
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well atezolizumab and cobimetinib work in treating patients with non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic), has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab and cobimetinib may work better in treating patients with non-small cell lung cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like strong or moderate inhibitors or inducers of CYP3A4 enzymes, and systemic immunosuppressive medications within 2 weeks before starting the trial. It's best to discuss your current medications with the study team.

Is the combination of Atezolizumab and Cobimetinib safe for humans?

Atezolizumab, also known as Tecentriq, has been shown to have an acceptable safety profile in clinical trials for lung cancer, with common side effects including fatigue, decreased appetite, and nausea. Serious side effects can include pneumonia and liver inflammation, but these are less common. Cobimetinib, known as Cotellic, is not specifically mentioned in the provided research, so its safety in combination with Atezolizumab is not detailed here.12345

How is the drug combination of Atezolizumab and Cobimetinib unique for treating lung cancer?

The combination of Atezolizumab and Cobimetinib is unique because Atezolizumab is an immunotherapy drug that blocks PD-L1, helping the immune system attack cancer cells, while Cobimetinib is a targeted therapy that inhibits a specific protein involved in cancer cell growth. This dual approach aims to enhance the body's immune response and directly target cancer cell pathways, offering a novel strategy compared to traditional chemotherapy.26789

What data supports the effectiveness of the drug Atezolizumab for lung cancer?

Research shows that Atezolizumab, a drug that helps the immune system fight cancer, has been effective in treating non-small cell lung cancer (NSCLC). It has shown promising results in improving outcomes for patients with advanced stages of this type of lung cancer.24101112

Who Is on the Research Team?

Stephen Liu, MD| Medical Oncology ...

Stephen V. Liu

Principal Investigator

JHU Sidney Kimmel Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

Adults with metastatic, recurrent, or treatment-resistant non-small cell lung cancer who have previously not responded well to anti-PD-1/PD-L1 therapy. Participants must be over 18, have measurable disease, and acceptable organ function. Those with certain gene mutations may join specific cohorts. Pregnant women and individuals with uncontrolled diseases or recent significant adverse events from cancer therapies are excluded.

Inclusion Criteria

My lung cancer is confirmed to be metastatic or recurrent through testing.
Your hemoglobin level is at least 8 grams per deciliter.
I have had treatments other than anti-PD-1 or anti-PD-L1 before joining this study.
See 18 more

Exclusion Criteria

You have had allergic reactions to drugs similar to atezolizumab or cobimetinib.
I do not have another cancer that needs treatment within 2 years, except for certain low-risk types.
I frequently need procedures to remove fluid from my chest or abdomen.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab intravenously and cobimetinib orally. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle
1 visit (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including CT scan, MRI, biopsy, and blood collection.

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Cobimetinib
Trial Overview The trial is testing the combination of atezolizumab (an immunotherapy drug) and cobimetinib (a kinase inhibitor for cancers with a mutated BRAF gene) in patients whose lung cancer has spread or resisted previous treatments. The study aims to see if this drug combo is more effective than current standard care.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, cobimetinib)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on days 1, and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Patients also undergo a CT scan, MRI, biopsy, and collection of blood throughout the trial.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Atezolizumab significantly improves overall survival (OS) and progression-free survival (PFS) in patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy, based on a meta-analysis of 7 randomized clinical trials involving 4,859 patients.
The effectiveness of atezolizumab varies based on clinical and molecular features, with better outcomes observed in younger patients, those with wild-type EGFR, and active or previous smokers, highlighting the importance of personalized treatment strategies.
Efficacy of Atezolizumab for Advanced Non-Small Cell Lung Cancer Based on Clinical and Molecular Features: A Meta-Analysis.Liu, W., Huo, G., Chen, P.[2022]
Atezolizumab, cemiplimab, and pembrolizumab are established as standard first-line immunotherapy options for patients with advanced non-small cell lung cancer (NSCLC) who have high PD-L1 expression (≥50%).
The consensus among 25 Spanish lung cancer experts indicates that these therapies can be tailored to specific patient subgroups, enhancing treatment decision-making based on differences observed in pivotal clinical trials.
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement.Isla, D., Sánchez, A., Casal, J., et al.[2023]
Atezolizumab significantly improved overall survival in patients with previously treated non-small-cell lung cancer compared to docetaxel, with median survival times of 13.8 months versus 9.6 months, respectively.
The safety profile of atezolizumab was favorable, with only 15% of patients experiencing grade 3 or 4 adverse events, compared to 43% in the docetaxel group, indicating it may be a safer treatment option.
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

Citations

Efficacy of Atezolizumab for Advanced Non-Small Cell Lung Cancer Based on Clinical and Molecular Features: A Meta-Analysis. [2022]
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement. [2023]
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]
Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]
Profile of atezolizumab in the treatment of metastatic non-small-cell lung cancer: patient selection and perspectives. [2023]
U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]
Safety and efficacy of atezolizumab in Chinese patients with previously treated locally advanced or metastatic non-small cell lung cancer: An open-label, single-arm, multicenter study. [2023]
Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. [2020]
Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]
Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]
Atezolizumab: First Global Approval. [2019]
Prospects and progress of atezolizumab in non-small cell lung cancer. [2019]
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