Combination of Chemotherapy and Gefitinib as First-line Treatment

NCT02148380 | Completed

• 1 other identifier: chest20140001
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Cancer

Keywords

Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  6-month

Secondary Outcomes (2)

• overall survival

  2 years

• to evaluate the safety profile between three groups

  6 months

Study Arms (3)

chemotherapy group(B)

EXPERIMENTAL

pemetrexed plus carboplatin pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) every 4 weeks for up to six cycles, then continued to receive pemetrexed(500 mg/m(2) on day 1) alone every 4 weeks

Drug: pemetrexed plus carboplatin

combination therapy group(A)

EXPERIMENTAL

pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5-21) and repeated every 4 weeks for up to six cycles,then continued to receive pemetrexed combined with gefitinib every 4 weeks.

Drug: pemetrexed plus carboplatin; Drug: gefitinib

gefitinib group (group C)

EXPERIMENTAL

received gefitinib( 250 mg/day)alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death

Drug: gefitinib

Interventions

pemetrexed plus carboplatin DRUG

Also known as: Alimita plus carboplatin

chemotherapy group(B); combination therapy group(A)

gefitinib DRUG

Also known as: Iressa

combination therapy group(A); gefitinib group (group C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baohui Han: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Related Publications (1)

• 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.

  PMID: 32170554 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin; Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Quinazolines

Study Officials

• Baohui Han, Dr

  Vice President of Shanghai Chest Hospital,Sponsor of study

  STUDY CHAIR

• Bo Jin, Dr

  Study Leader,Doctor of Shanghai Chest Hospital

  STUDY DIRECTOR

• Yanjie Niu, Master

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Yanwei Zhang, Dr

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Tianqing Chu, Dr

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Aiqin Gu, Master

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Lei Zhu, Master

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Jun Pei

  Doctor of Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the chief physician

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)