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

Lung Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02951637
• Other study ID #: Chest004
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 15, 2016
• Last updated: October 29, 2016
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: Shanghai Chest Hospital
• Contact: Aiqin Gu, MD
• Phone: 13916720655
• Email: Guaiqin11[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Neoplasms

Intervention

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.
• Gefitinib
Gefitinib (250mg daily)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Changhai Hospital, Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		16 months	No
Secondary	overall survival (OS)		32 months	No
Secondary	Objective response rate (ORR)		6 months	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		6 months	Yes