Clinical trial NCT02125240: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Official title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed description: This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed lung adenocarcinoma after surgical resection
* Stage II-IIIA disease according to 7th edition of TNM staging
* Patients must harbor sensitive EGFR gene mutation (19/21)
* Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

Exclusion Criteria:

* Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
* Presence of metastatic disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity from previous anticancer therapy
* Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Primary outcomes:
measure: Disease-free survival
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Lung cancer symptoms and health-related quality of life (HRQoL) differences
timeFrame: 60 months
measure: Number of participants with adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: China-japan friendship hospital in Beijing
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: 304 Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: People's Liberation Army General Hospital (301 Hospital)
state: Beijing
city: Beijing
country: China
facility: Capital Medical University, Beijing Chest Hospital
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: Yuan-Kai Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu YT, Hao XZ, Liu DR, Cheng G, Zhang SC, Xiao WH, Hu Y, Liu JF, He M, Ding CM, Zhang L, Wang J, Li H, Dong GL, Zhi XY, Li J, Shi YK. Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial. Cancer Manag Res. 2020 Jun 17;12:4633-4643. doi: 10.2147/CMAR.S240275. eCollection 2020.