GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Treatments: Gefitinib; Vinblastine; Vinorelbine

Criteria

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