Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04471428
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Docetaxel — DRUG
    Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Dec 2025
Primary completion
Sep 28, 2022
Completion
Jan 17, 2025

Study Design

Enrollment
366 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Cabozantinib
    Participants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle.
  • Active Comparator: Docetaxel
    Participants received docetaxel on Day 1 of each 21-day cycle.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 24 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305-
Kaiser Permanente - San DiegoSan DiegoCalifornia92120-
Sansum ClinicSanta BarbaraCalifornia93105-
Rocky Mountain Cancer CentersDenverColorado80220-
Regional Cancer Care AssociatesBethesdaMaryland20817-
Minnesota Oncology HematologySaint PaulMinnesota55102-
Consultants in Medical Oncology and HematologyBroomallPennsylvania19008-
Charleston Oncology, P .ACharlestonSouth Carolina29414-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Huntsman Cancer Institute at The University of UtahSalt Lake CityUtah84112-
Oncology and Hematology Associates of Southwest Virginia, Inc.,-BlacksburgBlacksburgVirginia24060-
Virginia Cancer Specialists (Fairfax) - USORFairfaxVirginia22031-

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAKaiser Permanente - San Diego· San Diego, CASansum Clinic· Santa Barbara, CARocky Mountain Cancer Centers· Denver, CORegional Cancer Care Associates· Bethesda, MDMinnesota Oncology Hematology· Saint Paul, MN

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