Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03600701
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Refractory Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Cobimetinib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Nov 29, 2018
Status verified
Oct 2025
Primary completion
Jul 14, 2025
Completion
Oct 3, 2026

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, cobimetinib)
    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.

Primary Outcome Measure

Durable response rate to therapy [ Time Frame: Up to 90 days ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
Moffitt Cancer CenterTampaFlorida33612-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Wake Forest University at ClemmonsClemmonsNorth Carolina27012-
Hayworth Cancer CenterHigh PointNorth Carolina27262-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUC San Diego Moores Cancer Center· La Jolla, CAMedStar Georgetown University Hospital· Washington D.C., DCMoffitt Cancer Center· Tampa, FLEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GA

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