Combination of Chemotherapy and Gefitinib as First-line Treatment

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148380
• Other study ID #: chest20140001
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: April 19, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Science and Technology Commission of Shanghai Municipality:China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• pemetrexed plus carboplatin

• gefitinib

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baohui Han

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		6-month	No
Secondary	overall survival		2 years	No
Secondary	to evaluate the safety profile between three groups	Toxicity will be graded according to NCI CTCAE, version 4.0. The analysis of safety/tolerability data will be descriptive; toxicity events will be individually tabulated.	6 months	Yes