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Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-Line Treatment in Locally Advanced Or Metastatic NSCLC Patients With Concomitant EGFR and Tumor Suppressor Gene Mutation: A Multicenter, Open-Label, Randomized, Controlled Phase III Study (ACROSS2)
This is a multicenter, randomized, controlled, phase III study.
Details
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 460 |
| Start date | 2020-10 |
| Completion | 2023-10 |
Conditions
- Non Small Cell Lung Cancer
Interventions
- Almonertinib
- Almonertinib plus carboplatin and pemetrexed
Primary outcomes
- Progression Free Survival (PFS) — From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
To assess the efficacy of Almonertinib compared with Almonertinib Plus carboplatin and pemetrexed as first line therapy to EGFRm+, locally advanced or metastatic NSCLC patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Countries
China