Clinical trial NCT02148380: Combination of Chemotherapy and Gefitinib as First-line Treatment
Official title: Combination of Chemotherapy and Gefitinib as First-line Treatment of Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small-Cell Lung Cancer
Keywords: Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Age \>=18 years
3. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
4. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
5. Measurable or non-measurable disease
6. Able to comply with study and follow-up procedures

Exclusion Criteria:

* Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
* Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer
* Symptomatic or untreated brain metastases
* Prior systemic chemotherapy for NSCLC
* Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
* History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
* Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
* Pregnancy or lactation

Primary outcomes:
measure: progression-free survival
timeFrame: 6-month
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
measure: to evaluate the safety profile between three groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Vice President of Shanghai Chest Hospital,Sponsor of study
name: Baohui Han, Dr
role: STUDY_CHAIR
affiliation: Study Leader,Doctor of Shanghai Chest Hospital
name: Bo Jin, Dr
role: STUDY_DIRECTOR
affiliation: Doctor of Shanghai Chest Hospital
name: Yanjie Niu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor of Shanghai Chest Hospital
name: Yanwei Zhang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor of Shanghai Chest Hospital
name: Tianqing Chu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor of Shanghai Chest Hospital
name: Aiqin Gu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor of Shanghai Chest Hospital
name: Lei Zhu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor of Shanghai Chest Hospital
name: Jun Pei
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lou Y, Xu J, Zhang Y, Lu J, Chu T, Zhang X, Wang H, Zhong H, Zhang W, Han B. Chemotherapy Plus EGFR-TKI as First-Line Treatment Provides Better Survival for Advanced EGFR-Positive Lung Adenocarcinoma Patients: Updated Data and Exploratory In Vitro Study. Target Oncol. 2020 Apr;15(2):175-184. doi: 10.1007/s11523-020-00708-y.