drugset / Trial / NCT04611776
A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2025-03-06
- Completion
- 2026-01-08
Outcome
Outcome not reported
Stopped (Enrollment): “The positive results from IMpower010 demonstrated benefit by adding atezolizumab as adjuvant therapy in early stage NSCLC. These results raised ethical concerns of enrolling pts to best supportive care over checkpoint inhibition in this setting.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |