GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study ID
NCT02319577
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oral vinorelbine — DRUG
    Anti-neoplastic drug (PO chemotherapeutical agent, vinka alkaloid)
  • Gefitinib — DRUG
    EGFR tyrosine kinase inhibitor

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Dec 2014
Primary completion
Jun 30, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gefitinib plus oral vinorelbine
    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
  • Active Comparator: Gefitinib alone
    Arm B (21-days cycles until progressive disease or unacceptable toxicity): Gefitinib 250 mg daily from day 1 to day 21

Primary Outcome Measure

Progression-free survival (PFS) rate at 6 months [ Time Frame: 6 months; tumor assessment is performed every 6 weeks from randomization until progressive disease ]

Central Contacts

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