Clinical trial NCT03656393: To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma
Official title: Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NSCLC
EGFR
Keywords: EGFR
NSCLC
Carboplatin
vinorelbine
Gefitinib
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: 2y DFS
timeFrame: 2 years
Secondary outcomes:
measure: ORR
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen People's Hospital
name: Qiu Chen, Doctor
role: STUDY_DIRECTOR
References: