NCT03058094

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hangzhou ACEA Pharmaceutical Research Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed will be administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. Folic acid will be administered 1-2 weeks prior to the 1st dose, then daily during the treatment period until 21days post the last dose. Vitamin B12 will be administered on the same day of pemetrexed infusion during the treatment period. Corticosteroid will be adminstered on the day prior to, on the day, and on the day after infusion.
DRUG	Cisplatin 75mg/m2	Cisplatin will be administered as an intravenous infusion.
DRUG	AC0010	300mg, orally, BID

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2017-02-20
• Last updated: 2019-02-04

Locations

21 sites across 1 country: China