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

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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC; EGFR
• Intervention / Treatment: Drug: Gefitinib; Drug: Vinorelbine; Drug: Carboplatin

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wang Lingwei, Doctor; Phone Number: 15914030269; Email: limey@sina.com
• Study Contact Backup: Name: Wang Guangsuo, Doctor; Phone Number: 13590437796; Email: 908611104@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: wang wei, Doctor; Phone Number: 15914030296; Email: limey@sina.com
      • Contact: wang suo, Doctor; Phone Number: 13590437796; Email: 908611104@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Carboplat; Ercar; Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2y DFS	2-year disease-free survival	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	objective response rates	6 months

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Study Director: Qiu Chen, Doctor, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2018
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; EGFR; Carboplatin; Gefitinib; vinorelbine
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Carboplatin; Gefitinib; Vinorelbine
• Other Study ID Numbers: SZLY2017024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No