Combination of Chemotherapy and Gefitinib as First-line Treatment

• ClinicalTrials.gov Identifier: NCT02148380
• Recruitment Status: Completed
• First Posted: May 28, 2014
• Last Update Posted: April 20, 2016
• Sponsor: Baohui Han
• Information provided by (Responsible Party): Baohui Han, Shanghai Chest Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small-Cell Lung Cancer	Drug: pemetrexed plus carboplatin; Drug: gefitinib	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: 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 Start Date: May 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: chemotherapy group(B); 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; Other Name: Alimita plus carboplatin
Experimental: combination therapy group(A); 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; Other Name: Alimita plus carboplatin; Drug: gefitinib; Other Name: Iressa
Experimental: gefitinib group (group C); received gefitinib( 250 mg/day)alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death	Drug: gefitinib; Other Name: Iressa

Outcome Measures

Primary Outcome Measures :

1. progression-free survival [ Time Frame: 6-month ]

Secondary Outcome Measures :

1. overall survival [ Time Frame: 2 years ]
2. to evaluate the safety profile between three groups [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China

Shanghai Chest Hospital

Shanghai, China, 200030

Sponsors and Collaborators

Baohui Han

Investigators

• Study Chair: Baohui Han, Dr; Vice President of Shanghai Chest Hospital,Sponsor of study
• Study Director: Bo Jin, Dr; Study Leader,Doctor of Shanghai Chest Hospital
• Principal Investigator: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Baohui Han, the chief physician, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT02148380
• Other Study ID Numbers: chest20140001
• First Posted: May 28, 2014
• Last Update Posted: April 20, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Baohui Han, Shanghai Chest Hospital:

Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib

Additional relevant MeSH terms:

Carboplatin; Pemetrexed; Gefitinib; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors