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

NCT03656393 | Unknown Phase 3 DMC

• 1 other identifier: SZLY2017024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; EGFR

Keywords

EGFR; NSCLC; Carboplatin; vinorelbine; Gefitinib

Outcome Measures

Primary Outcomes (1)

• 2y DFS

  2-year disease-free survival

  2 years

Secondary Outcomes (1)

• ORR

  6 months

Study Arms (2)

Gefitinib therapy group

EXPERIMENTAL

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

Vinorelbine combination therapy group

ACTIVE COMPARATOR

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; Drug: Carboplatin

Interventions

Gefitinib DRUG

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

Also known as: Iressa

Gefitinib therapy group

Vinorelbine DRUG

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

Also known as: 5'-noranhydrovinblastine, 5-Nonylthio-8-methylthio-chinolin

Vinorelbine combination therapy group

Carboplatin DRUG

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

Also known as: Paraplatin, Carboplat, Ercar

Vinorelbine combination therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Interventions

Gefitinib; Vinorelbine; Carboplatin

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Coordination Complexes; Organic Chemicals

Study Officials

• Qiu Chen, Doctor

  Shenzhen People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Wang Lingwei, Doctor

CONTACT

15914030269; limey@sina.com

Wang Guangsuo, Doctor

CONTACT

13590437796; 908611104@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: September 4, 2018
• Study Start: August 31, 2018
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

CN (1)