Clinical trial · Interventional
To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma
Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer
NCT03656393CI-TRIAL-00034695RCTACSCNSCLCunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gefitinib therapy group
- description
- 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.
- interventionNames
- Drug: Gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Vinorelbine combination therapy group
- description
- 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.
- interventionNames
- Drug: Vinorelbine
- Drug: Carboplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.