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

Sponsor

Shenzhen People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03656393

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC EGFR	Drug: Gefitinib Drug: Vinorelbine Drug: Carboplatin	Phase 3

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer

Anticipated Study Start Date :

Aug 31, 2018

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Gefitinib Gefitinib (250 mg, orally, every day) for 56 days Other Names: Iressa
Active Comparator: 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.	Drug: Vinorelbine Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks Other Names: 5'-noranhydrovinblastine 5-Nonylthio-8-methylthio-chinolin Drug: Carboplatin Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks Other Names: Paraplatin Carboplat Ercar

Arm

Intervention/Treatment

Experimental: 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.

Drug: Gefitinib

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

Other Names:

Iressa

Active Comparator: 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.

Drug: Vinorelbine

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

Other Names:

5'-noranhydrovinblastine

5-Nonylthio-8-methylthio-chinolin

Drug: Carboplatin

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

Other Names:

Paraplatin

Carboplat

Ercar

Outcome Measures

Primary Outcome Measures

2y DFS [2 years]
2-year disease-free survival

Secondary Outcome Measures

ORR [6 months]
objective response rates

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;
The gene detects EGFR mutations is positive;
The age is between 18-70 years;
ECOG 0-1;
Liver and kidney function and Bone marrow hematopoiesis is normal;
There are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition;
No other malignant diseases within 5 years;
Patients who have not received radiotherapy, systemic chemotherapy, or biological therapy;
Understand the whole process of the trial and voluntarily participate in and sign the informed consent form.

Exclusion Criteria:

The tumor has invaded the surrounding tissue;
Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;
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;
severe hypertension with poor drug control;
moderate to severe proteinuria;
HIV fluHistory of infection or active chronic hepatitis B or C;
Malnutrition, decompensation of organ function;
History of chest radiotherapy;
Incomplete inflammation of eyes;
Patients with seizures that need to be treated;
Interstitial pneumonia;
Drug abuse and others that may interfere with patients' participation in the study or studyThe assessment of the results has an impact;
Allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test;
Any instability. The condition of the patient may jeopardize patient safety and compliance;
Pregnancy or breastfeeding women and having fertility without adequate contraception.