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

Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Lung Adenocarcinoma
• Intervention / Treatment: Drug: Pemetrexed plus carboplatin combined with gefitinib; Drug: Gefitinib

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Aiqin Gu, MD; Phone Number: 13916720655; Email: Guaiqin11@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib	Drug: 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.; Other Names: Combination of chemotherapy and EGFR TKI
Experimental: Group B; Patient will be administrated with gefitinib	Drug: Gefitinib; Gefitinib (250mg daily); Other Names: EGFR TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	16 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	6 months
Objective response rate (ORR)	6 months
overall survival (OS)	32 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Changhai Hospital; Ruijin Hospital
• Investigators: Principal Investigator: Aiqin Gu, MD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 15, 2016
• First Submitted That Met QC Criteria: October 29, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 29, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Folic Acid Antagonists; Carboplatin; Gefitinib; Pemetrexed
• Other Study ID Numbers: Chest004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED