Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Phase 4

• Conditions: EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma
• Interventions: Drug: Experimental; Drug: Chemotherapy

• Registration Number: NCT01665417
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed Description

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.

Primary endpoint:

Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib

Secondary endpoint:

1. Overall survival between icotinib and chemotherapy

2. Time to Progression between icotinib and chemotherapy

3. Objective response rate and disease control rate between icotinib and chemotherapy

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).

Exclusion Criteria

• Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Icotinib	Experimental	Icotinib: 125mg, oral administration, three times per day.
Chemotherapy Regimen 2	Chemotherapy	Chemotherapy Regimen 2：Docetaxel 75 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
Chemotherapy Regimen 1	Chemotherapy	Chemotherapy Regimen 1：Pemetrexe 500 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	8 months	PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3 months	Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.
Time to Tumor Progression	8 months	TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Overall survival	24 months	OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Number of participants with adverse events	24 months	Adverse events assessed by CTCAE4.0.

Trial Locations

Locations (1)

Chinese People's Liberation Army (PLA) General Hospital; 🇨🇳 Beijing, Beijing, China