An international multicenter randomized phase III study of first-line Erlotinib followed by second-line Cisplatin Gemcitabine versus first-line Cisplatin Gemcitabine followed by second-line Erlotinib in advanced non small cell lung cancer - TORCH

Active, not recruiting

• Conditions: advanced non small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2005-005968-90-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Diagnosis of cytologically or histologically confirmed non-small cell lung cancer Metastatic stage IV or locally advanced stage IIIB, with metastasis to supraclavicular nodes or with pleural effusion Both patients at first diagnosis or those with disease recurrence after former surgery are eligible. At least one target or non-target lesion according to RECIST Male or female 18 and 70 years of age except for Canadian centers that will not apply the upper age limit ECOG PS 0 or 1 Life expectancy of 3 months Neutrophils 1.5 x 109/L, platelets 100 x 109/L, and hemoglobin 9 g/dL Bilirubin level either normal or 1.5 x ULN AST SGOT and ALT SGPT 2.5 x ULN 5 x ULN if liver metastasis are present Serum creatinine 1.5 x ULN Effective contraception for both, male and female patients if the risk of conception exists Signed written informed consent
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

Prior exposure to agents directed at the HER axis e.g. gefitinib, cetuximab, trastuzumab . Prior chemotherapy or therapy with systemic anti-neoplastic therapy e.g., monoclonal antibody therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior neoadjuvant chemotherapy for operable disease or adjuvant chemotherapy is permitted if it did not contain gemcitabine and if at least 1 year elapsed from the end of chemotherapy and the date of relapse. Any unstable systemic disease including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease , metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications. Any other malignancies within 5 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA . Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease clinically stable imaging for at least 2 months will also cause patients to be excluded. Patients with asymptomatic CNS metastases and not requiring steroids to control symptoms can be included, even if on anti-seizure medications. HIV positive patients Any inflammatory changes of the surface of the eye at baseline Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. Nursing and/or pregnant women. Known or suspected hypersensitivity to any of the study drugs

Study & Design

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