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

NSCLC Clinical Trial

— RCTACSCNSCLC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03656393
• Other study ID #: SZLY2017024
• Status: Recruiting
• Phase: Phase 3
• Start date: August 31, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2018
• Source: Shenzhen People's Hospital
• Contact: Wang Lingwei, Doctor
• Phone: 15914030269
• Email: limey[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• EGFR
• NSCLC

Intervention

Drug:
• Gefitinib
Gefitinib (250 mg, orally, every day) for 56 days
• Vinorelbine
Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
• Carboplatin
Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2y DFS	2-year disease-free survival	2 years
Secondary	ORR	objective response rates	6 months