GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial

NCT02319577 | Unknown Phase 2

• 1 other identifier: Genoa trial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; EGFR; vinorelbine; gefitinib

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate at 6 months

  Progression-free survival is defined as the time from randomization until disease progression or death due to any cause.

  6 months; tumor assessment is performed every 6 weeks from randomization until progressive disease

Secondary Outcomes (3)

• Overall survival (OS) rate at 1 year (1Y-OS), 2 years (2Y-OS), and 3 years (3Y-OS)

  Overall survival assessment is performed at every visit from randomization of each patient until his/her death

• Response rate (RR)

  tumor assessment is performed every 6 weeks from the start of study treatment until progressive disease

• Safety profile: Safety will be assessed by medical interview, physical examination, and blood collection for complete blood count on days 1 and 8 and biochemistry

  assessment of safety profile is performed at every visit (on day 1 and day 8 of each 21-days cycle) from the start of study treatment until three weeks after its interruption due to intolerance or progressive disease

Study Arms (2)

Gefitinib plus oral vinorelbine

EXPERIMENTAL

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

Drug: oral vinorelbine; Drug: Gefitinib

Gefitinib alone

ACTIVE COMPARATOR

Arm B (21-days cycles until progressive disease or unacceptable toxicity): Gefitinib 250 mg daily from day 1 to day 21

Drug: Gefitinib

Interventions

oral vinorelbine DRUG

Anti-neoplastic drug (PO chemotherapeutical agent, vinka alkaloid)

Also known as: Navelbine

Gefitinib plus oral vinorelbine

Gefitinib DRUG

EGFR tyrosine kinase inhibitor

Also known as: Iressa

Gefitinib alone; Gefitinib plus oral vinorelbine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: lead

Study Sites (1)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genova, Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Francesco Grossi, MD

  IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Grossi, MD

CONTACT

+39 010 5600385; francesco.grossi@hsanmartino.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 18, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

IT (1)