This trial is active, not recruiting.

Condition nsclc
Treatments icotinib, chemotherapy
Phase phase 3
Target EGFR
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date December 2012
End date September 2016
Trial size 296 participants
Trial identifier NCT01719536, BD-IC-IV36


The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Icotinib 125mg is administered orally three times per day.
icotinib BPI-2009
Icotinib: 125 mg is administered orally three times per day.
(Active Comparator)
Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
chemotherapy ALIMTA
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.

Primary Outcomes

Progression Free Survival
time frame: 12 months

Secondary Outcomes

Overall survival
time frame: 20 months
Objective response rate
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients. - Positive EGFR Mutation. - No previous systemic anticancer therapy. - Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. - Provision of written informed consent. Exclusion Criteria: - Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab. - Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). - Known severe hypersensitivity to icotinib or any of the excipients of this product. - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Additional Information

Official title Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Principal investigator Shi Yuankai, M.D.
Description This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation,primary endpoint is progress-free survival,second endpoints include overall survival, time to progression, and so on.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..