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

Betta Pharmaceuticals Co., Ltd.100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma

Interventions

ExperimentalDRUG

Icotinib: 125mg, oral administration, three times per day.

ChemotherapyDRUG

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.

ChemotherapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival

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.

Time frame: 8 months

Secondary Outcomes

Overall survival

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.

Time frame: 24 months

Time to Tumor Progression

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.

Time frame: 8 months

Objective response rate

Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.

Time frame: 3 months

Number of participants with adverse events

Adverse events assessed by CTCAE4.0.

Time frame: 24 months

Central Contacts

Jiao Shunchang, MD

CONTACT

0086-13801380677

Data from ClinicalTrials.gov

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