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

Completed · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 facts

Study ID: NCT04471428
Run by: Hoffmann-La Roche
People needed: 366
Starts: 2020-10-01
Expected to finish: 2025-01-17
Last updated by the study team: 2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed metastatic NSCLC
Documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC
Measurable disease per RECIST v1.1 outside CNS as assessed by investigator
Known PD-L1 status or availability of tumor tissue for central PD-L1 testing
ECOG Performance Status score of 0 or 1
Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator
Adequate hematologic and end-organ function
Negative HIV test at screening
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs,
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

You may not qualify if…

Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene
Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly)
Severe hepatic impairment
Uncontrolled or symptomatic hypercalcemia
Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast
Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment
Significant vascular disease within 6 months of initiation of study treatment
Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion on the investigator, could impact patient safety
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Current treatment with anti-viral therapy for HBV
Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
Pregnant or lactating females, or intention of becoming pregnant during the treatment with atezolizumab in combination with cabozantinib in the experimental arm or during the treatment with docetaxel in the control arm, or within 5 months after the final dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever is later.
Ongoing Grade >= 2 sensory or motor neuropathy
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions: Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Rash must cover < 10% of body surface area.
Pharmacologically uncompensated, symptomatic hypothyroidism
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic stem cell or solid organ transplantation

Where it is running

Kaiser Permanente - San Diego — San Diego, California, United States
Sansum Clinic — Santa Barbara, California, United States
Rocky Mountain Cancer Centers — Denver, Colorado, United States
Regional Cancer Care Associates — Bethesda, Maryland, United States
Minnesota Oncology Hematology — Saint Paul, Minnesota, United States
Consultants in Medical Oncology and Hematology — Broomall, Pennsylvania, United States
Charleston Oncology, P .A — Charleston, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
Huntsman Cancer Institute at The University of Utah — Salt Lake City, Utah, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg — Blacksburg, Virginia, United States
Virginia Cancer Specialists (Fairfax) - USOR — Fairfax, Virginia, United States
Royal North Shore Hospital — St Leonards, New South Wales, Australia
Townsville Hospital — Townsville, Queensland, Australia
Flinders Medical Centre — Bedford Park, South Australia, Australia
Austin Hospital Olivia Newton John Cancer Centre — Heidelberg, Victoria, Australia
Affinity Oncology — Nedlands, Western Australia, Australia
Lkh-Univ. Klinikum Graz — Graz, Austria
Ordensklinikum Linz Elisabethinen — Linz, Austria
Lhk Feldkirch — Rankweil, Austria
Lkh Salzburg - Univ. Klinikum Salzburg — Salzburg, Austria
Medizinische Universität Wien — Vienna, Austria
Institut Jules Bordet — Anderlecht, Belgium
Cliniques Universitaires St-Luc — Brussels, Belgium
Clinique Ste-Elisabeth — Namur, Belgium
Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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