Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

Phase 3

Completed

• Conditions: NSCLC
• Interventions: Drug: Chemotherapy; Drug: Icotinib

• Registration Number: NCT01719536
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Detailed Description

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-11-01
• Study Start: 2012-12
• Primary Completion: 2016-09
• Study Completion: 2017-02-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
• Positive EGFR 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.
• Provision of written informed consent.

Exclusion Criteria

• Experience of 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.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
Icotinib	Icotinib	Icotinib 125mg is administered orally three times per day.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	12 months	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	12 weeks	Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Overall survival	20 months	Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

Trial Locations

Locations (21)

The First Affiliated Hospital of Anhui Medical Univercity; 🇨🇳 Hefei, Anhui, China

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

Beijing Hospital for Chest Tumors & Tuberculosis Diseases; 🇨🇳 Beijing, Beijing, China

Xinqiao Hospital, The Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital Of Guangzhou Medical Collage; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hebei Provincal Tumor Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical Univercity Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Henan Provincal Tumor Hospital; 🇨🇳 Zhengzhou, Henan, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

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