CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 366 enrolled
Drug / intervention
Cabozantinib +2 moredrug
Likely dose
Cabozantinib 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04471428
NCT04471428Phase 3Completed

A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

Hoffmann-La Roche·interventional·Posted Jul 15, 2020·Updated Dec 22, 2025

In Brief

A Phase 3 clinical trial evaluating Cabozantinib, Atezolizumab, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 366 participants across 92 sites in 15 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Poland, Portugal, Russia, South Korea, Spain, United Kingdom, United States
CollaboratorsExelixis

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 15, 2020
Enrollment StartOct 1, 2020
Primary CompletionSep 28, 2022
Study CompletionJan 17, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.0 years ago

Interventions

Cabozantinibdrug

Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.

Atezolizumabdrug

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Docetaxeldrug

Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.