Clinical trial · Interventional
GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial
Randomized, Phase II Study With Gefitinib Plus Vinorelbine Versus Gefitinib Alone in Patients Affected by Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of EGFR
- 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)
A sub-population of patients affected by non-small cell lung cancer (NSCLC) with activating mutations of the epidermal growth factor receptor (EGFR) do not gain benefit from treatment with tyrosine-kinase inhibitors (TKIs). The hypothesis of this study is that the addition of chemotherapy with oral vinorelbine to first-line TKI might result in improved outcomes in EGFR-mutated patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
| oral vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gefitinib plus oral vinorelbine
- description
- Arm A (21-days cycles until progressive disease or unacceptable toxicity): Oral vinorelbine 60 mg/mq on days 1,8 Gefitinib 250 mg daily from day 9 to day 21
- interventionNames
- Drug: oral vinorelbine
- Drug: Gefitinib
- type
- ACTIVE_COMPARATOR
- label
- Gefitinib alone
- description
- Arm B (21-days cycles until progressive disease or unacceptable toxicity): Gefitinib 250 mg daily from day 1 to day 21
- interventionNames
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * At least 18 years old * Histologically confirmed NSCLC * Stage IV disease * Evidence of activating mutations of EGFR * Measurable disease (assessed by RECIST 1.1) * No previous chemotherapy or biological therapy for NSCLC * Previous radiation treatment is allowed, unless all the eligible target lesions have been irradiated, and provided that at least 2 weeks have passed from the end of radiation therapy to the start of the treatment in the study * Eastern Cooperative Oncology Group (ECOG) performance status : 0-1 * Adequate baseline bone marrow, hepatic and renal function * In presence of central nervous system metastases, the patient has to be asymptomatic for at least 4 weeks before starting treatment in the study * Patients who had received neoadjuvant or adjuvant chemotherapy, or concurrent chemo-radiation for non-metastatic, radically treated NSCLC are considered eligible, provided that they had not received vinorelbine as part of such treatment * Female patients must provide a negative pregnancy test (serum or urine) prior to treatment Exclusion Criteria: * Other malignancies within the last 3 years, with exclusion of non-melanoma skin neoplasms and in-situ carcinoma of the cervix * Grade III-IV New York Heart Association (HYHA) cardiac dysfunction * Acute myocardial infarction or pulmonary embolism in the last 6 months * Brain metastases or meningeal carcinomatosis or spinal cord compression, unless controlled and asymptomatic for at least 30 days before starting study treatment * HIV positivity or AIDS requiring pharmacological treatment * Pregnancy or lactation
References
Publications (0)
Data not yet available