Overview

This trial is active, not recruiting.

Conditions egfr positive non-small cell lung cancer, adenocarcinoma
Treatments sequential and maintenance icotinib, maintenance icotinib
Phase phase 4
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date July 2014
End date July 2017
Trial size 100 participants
Trial identifier NCT02194556, BD-IC-IV69

Summary

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
sequential and maintenance icotinib Gemzar
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
(Active Comparator)
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.
maintenance icotinib Gemzar
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.

Primary Outcomes

Measure
Progression Free Survival
time frame: 15 months

Secondary Outcomes

Measure
Overall survival
time frame: 24 months
Objective response rate
time frame: 24 months
Adverse events
time frame: 24 months
Disease control rate (DCR)
time frame: 24 months

Eligibility Criteria

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

Inclusion Criteria: - Stage IV or IIIB advanced non-small cell lung cancer patients - Positive EGFR Mutation - Non-progressive disease after first-line gemcitabine/cisplatin therapy - Measurable lesion according to RECIST 1.1 with at least one measurable lesion Exclusion Criteria: - Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on - Patients with wild-type EGFR - Evidence of interstitial lung diseases - 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 Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study
Principal investigator Xiaohua Hu, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..