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

• ClinicalTrials.gov Identifier: NCT02951637
• Recruitment Status: Unknown
• First Posted: November 1, 2016
• Last Update Posted: November 1, 2016
• Sponsor: Shanghai Chest Hospital
• Collaborators: Ruijin Hospital; Changhai Hospital
• Information provided by (Responsible Party): Aiqin Gu, Shanghai Chest Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Adenocarcinoma	Drug: Pemetrexed plus carboplatin combined with gefitinib; Drug: Gefitinib	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
• Study Start Date: December 2016
• Estimated Primary Completion Date: April 2018
• Estimated Study Completion Date: December 2019

Arms and Interventions

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 Name: Combination of chemotherapy and EGFR TKI
Experimental: Group B; Patient will be administrated with gefitinib	Drug: Gefitinib; Gefitinib (250mg daily); Other Name: EGFR TKI

Outcome Measures

Primary Outcome Measures :

1. Progression-free survival (PFS) [ Time Frame: 16 months ]

Secondary Outcome Measures :

1. overall survival (OS) [ Time Frame: 32 months ]
2. Objective response rate (ORR) [ Time Frame: 6 months ]
3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Aiqin Gu, MD; 13916720655; Guaiqin11@126.com

Sponsors and Collaborators

Shanghai Chest Hospital

Ruijin Hospital

Changhai Hospital

Investigators

• Principal Investigator: Aiqin Gu, MD; Shanghai Chest Hospital

More Information

• Responsible Party: Aiqin Gu, Principal Investigator, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT02951637
• Other Study ID Numbers: Chest004
• First Posted: November 1, 2016
• Last Update Posted: November 1, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Aiqin Gu, Shanghai Chest Hospital:

Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin

Additional relevant MeSH terms:

Adenocarcinoma; Adenocarcinoma of Lung; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carboplatin; Pemetrexed; Gefitinib; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors