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

NCT03058094 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-02-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Hangzhou ACEA Pharmaceutical Research Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, MD. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058094 on ClinicalTrials.gov