Phase II study of cetuximab in combination with cisplatin-docetaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC): a biomarker-based assessment of activity. - ND

• Conditions: on small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10001183; MedDRA version: 9.1Level: LLTClassification code 10025038

• Registration Number: EUCTR2008-008387-27-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The patient must give written (personally signed and dated) informed consent before completing any study related procedure. Males or females >= 18 years and < 70years. Histologically/citologically confirmed non-small-cell lung cancer (NSCLC). Unresectable stage IIIB-IV NSCLC. ECOG performance status <= 1. Life expectancy >= 12 weeks. Adequate hematological, hepatic and renal functions. Prior radiotherapy allowed, only in case of presence of at least one measurable lesion outside an irradiated area. Radiotherapy must have been completed at least 2 weeks before registration. At baseline, presence of at least one measurable target lesion according to RECIST criteria Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents and experimental therapy for advanced disease; The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized within 6 months before entering the study. Patients who are: pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. patients with active serious infection, diabetes mellitus, patients with concurrent heart failure [New York Heart Association (NYHA) class II-III-IV], or with progressive or unstable angina, patients who have had myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. Treatment with any investigational drug within the 30 days prior to registration. Concomitant treatment with any other anticancer drug. Known hypersensitivity to the study drugs or to drugs with similar chemical structures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified