Clinical trial NCT02486354: Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy
Official title: Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer \[AJCC\] 6th edition of tumor-node-metastasis \[TNM\] staging system) NSCLC patients
* Progressed after at least one platinum-based chemotherapy regimen at entry
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
* Adequate hematologic and biochemical values

Exclusion Criteria:

* Patients with symptomatic brain metastases
* Malignant tumor within the previous five years
* Severe infection; congestive heart failure
* Previous treatment with drugs targeting EGFR
* History of interstitial lung disease

Primary outcomes:
measure: progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 12 months
measure: objective response rate
timeFrame: 2 months
measure: number of patients suffered adverse events
timeFrame: 15 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Bejing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital
state: Beijing
city: Chongqing
country: China
facility: Third Affiliated Hospital, Third Military Medical University
state: Chongqing
city: Guanzhou
country: China
facility: Sun yat-sen Univerisity Cancer Center
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: Yan Sun, MD
role: STUDY_CHAIR
References:
citation: Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.
citation: Hu X, Zhang L, Shi Y, Zhou C, Liu X, Wang D, Song Y, Li Q, Feng J, Qin S, Xv N, Zhou J, Zhang L, Hu C, Zhang S, Luo R, Wang J, Tan F, Wang Y, Ding L, Sun Y. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study. PLoS One. 2015 Nov 24;10(11):e0142500. doi: 10.1371/journal.pone.0142500. eCollection 2015.