Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments routine dose icotinib, higher dose icotinib
Phase phase 2
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date January 2014
End date June 2016
Trial size 64 participants
Trial identifier NCT02027090, BD-IC-IV17

Summary

We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

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
(Experimental)
Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.
higher dose icotinib Commana
After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
(Active Comparator)
Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.
routine dose icotinib Commana
Icotinib is administered 125 mg three times daily.

Primary Outcomes

Measure
Progression-free survival
time frame: 5 months

Secondary Outcomes

Measure
Overall survival
time frame: 18 months
Response rate assessed using the RECIST criteria
time frame: 2 months
The number of patients who suffered adverse events
time frame: 30 months

Eligibility Criteria

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

Inclusion Criteria: - Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology); - Pretreated with at least 1 platinum-based chemotherapy; - No previous targeted treatment such as gefitinib, erlotinib; - With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria; - WHO performance status(PS)<= 2; - Adequate organ functions; - Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: - Allergic to icotinib; - Patients with metastatic brain tumors with symptoms; - Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab; - Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Additional Information

Official title High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study
Principal investigator Shun Lu, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..