Combination of Chemotherapy and Gefitinib as First-line Treatment

Baohui Han

Status: Completed

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: gefitinib; Drug: pemetrexed plus carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02148380

chest20140001

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 3 patient groups

chemotherapy group(B)

Experimental group

Description:

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

Treatment:

Drug: pemetrexed plus carboplatin

combination therapy group(A)

Experimental group

Description:

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.

Treatment:

Drug: pemetrexed plus carboplatin

Drug: gefitinib

gefitinib group (group C)

Experimental group

Description:

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

Treatment:

Drug: gefitinib