To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma

NCT ID: NCT03656393

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-09-30

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.

Detailed Description

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality.

OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS).

Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).

Conditions

NSCLC; EGFR

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gefitinib therapy group

Patients are treated with Gefitinib (250 mg, orally, every day) for 56 days and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.

Group Type: EXPERIMENTAL

Gefitinib

Intervention Type: DRUG

Gefitinib (250 mg, orally, every day) for 56 days

Vinorelbine combination therapy group

Patients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.

Group Type: ACTIVE_COMPARATOR

Vinorelbine

Intervention Type: DRUG

Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks

Carboplatin

Intervention Type: DRUG

Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks

Interventions

Gefitinib

Gefitinib (250 mg, orally, every day) for 56 days

Intervention Type: DRUG

Vinorelbine

Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks

Intervention Type: DRUG

Carboplatin

Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks

Intervention Type: DRUG

Other Intervention Names

Iressa; 5'-noranhydrovinblastine; 5-Nonylthio-8-methylthio-chinolin; Paraplatin; Carboplat; Ercar

Eligibility Criteria

Inclusion Criteria

1. The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;

2. The gene detects EGFR mutations is positive;

3. The age is between 18-70 years;

4. ECOG 0-1;

5. Liver and kidney function and Bone marrow hematopoiesis is normal;

6. There are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition;

7. No other malignant diseases within 5 years;

8. Patients who have not received radiotherapy, systemic chemotherapy, or biological therapy;

9. Understand the whole process of the trial and voluntarily participate in and sign the informed consent form.

Exclusion Criteria

1. The tumor has invaded the surrounding tissue;

2. Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;

3. Arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin Except), symptomatic coronary artery disease or myocardium. Ischemic or congestive heart failure exceeds NYHA class II;

4. severe hypertension with poor drug control;

5. moderate to severe proteinuria;

6. HIV fluHistory of infection or active chronic hepatitis B or C;

7. Malnutrition, decompensation of organ function;

8. History of chest radiotherapy;

9. Incomplete inflammation of eyes;

10. Patients with seizures that need to be treated;

11. Interstitial pneumonia;

12. Drug abuse and others that may interfere with patients' participation in the study or studyThe assessment of the results has an impact;

13. Allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test;

14. Any instability. The condition of the patient may jeopardize patient safety and compliance;

15. Pregnancy or breastfeeding women and having fertility without adequate contraception.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiu Chen, Doctor

Role: STUDY_DIRECTOR

Shenzhen People's Hospital

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Lingwei, Doctor

Role: CONTACT

limey@sina.com

15914030269

Wang Guangsuo, Doctor

Role: CONTACT

908611104@qq.com

13590437796

Facility Contacts

wang wei, Doctor

Role: primary

limey@sina.com

15914030296

wang suo, Doctor

Role: backup

908611104@qq.com

13590437796

Other Identifiers

SZLY2017024

Identifier Type: -

Identifier Source: org_study_id