Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

NCT ID: NCT02951637

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-12-31

Brief Summary

The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

Detailed Description

The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.

In addition, the overall survival and safety index will be collected for analyses.

Conditions

Lung Adenocarcinoma

Keywords

Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib

Group Type: EXPERIMENTAL

Pemetrexed plus carboplatin combined with gefitinib

Intervention Type: DRUG

Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.

Group B

Patient will be administrated with gefitinib

Group Type: EXPERIMENTAL

Gefitinib

Intervention Type: DRUG

Gefitinib (250mg daily)

Interventions

Pemetrexed plus carboplatin combined with gefitinib

Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.

Intervention Type: DRUG

Gefitinib

Gefitinib (250mg daily)

Intervention Type: DRUG

Other Intervention Names

Combination of chemotherapy and EGFR TKI; EGFR TKI

Eligibility Criteria

Inclusion Criteria

1. Patients had to voluntarily join the study and give written informed consent for the study;

2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);

3. A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)

4. Sensitive EGFR mutations (19del, 21L858R);

5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;

6. Patients did not receive systemic anti-cancer therapy previously;

7. Able to comply with study and follow-up procedures;

8. Age >= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;

Exclusion Criteria

1. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);

2. Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;

3. EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;

4. Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];

5. Symptomatic or untreated brain metastases;

6. 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);

7. 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;

8. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;

9. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aiqin Gu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiqin Gu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Central Contacts

Aiqin Gu, MD

Role: CONTACT

Phone: 13916720655

Email: Guaiqin11@126.com

Other Identifiers

Chest004

Identifier Type: -

Identifier Source: org_study_id