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A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

NSCLC Clinical Trial

Official title:
A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI

Clinical Trial Summary

A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI.

Clinical Trial Description

This is a phase III, open label, randomized study assessing AC0010 (300 mg, BID) versus pemetrexed/cisplatin (4-6 cycles) in patients with advanced NSCLC, who have progressed following prior therapy with EGFR-TKI.

Patients must provide a biopsy for central confirmation of T790M mutation positive. Eligible patients will be randomized (2:1) into AC0010 group or pemetrexed/cisplatin group. Patients in chemotherapy group can cross-over to AC0010 treatment when patients experience disease progression or intolerability of chemotherapy. The primary objective of the study is to compare the PFS of AC0010 and pemetrexed/cisplatin. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03058094
Study type Interventional
Source Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Contact
Status Withdrawn
Phase Phase 3
Start date December 2018
Completion date January 2020
View Details
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