Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments icotinib with concurrent radiotherapy, chemoradiotherapy
Phase phase 2
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date August 2014
End date August 2018
Trial size 120 participants
Trial identifier NCT02215356, BD-IC-IV66

Summary

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

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
Arm
(Active Comparator)
Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times). Progressive patients will be administered oral icotinib 125 mg three times daily.
chemoradiotherapy VP16
Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
(Experimental)
Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth. Maintenance icotinib will be administered after radiotherapy. Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
icotinib with concurrent radiotherapy Icotinib
Icotinib: 125 mg is administered orally three times per day.

Primary Outcomes

Measure
Progression-free survival
time frame: 24 months

Secondary Outcomes

Measure
Overall survival
time frame: 36 months
Objective response rate
time frame: 8 weeks
Adverse events
time frame: 54 months

Eligibility Criteria

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

Inclusion Criteria: - Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 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 - ECOG Performance Status of 0 to 1 Exclusion Criteria: - Prior treatment with 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

Additional Information

Official title Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
Principal investigator Lvhua Wang, MD
Description This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..