A RANDOMIZED PHASE II TRIAL OF PEMETREXED WITH OR WITHOUT PF- 3512676 FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER AFTER FAILURE OF ONE PRIOR CHEMOTHERAPY REGIMEN FOR ADVANCED DISEASE - ND

• Conditions: ocally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of one prior chemotherapy regimen for advanced disease.; MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2006-001588-52-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-14
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) 2. Locally advanced or metastatic NSCLC not amenable to curative treatment 3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as >/=20 mm with conventional techniques or >/=10 mm with spiral CT scan within 28 days prior to treatment (RECIST criteria) 4. Prior treatment with platinum-based chemotherapy for advanced NSCLC 5. Evidence of progressive disease following prior platinum-based chemotherapy 6. Prior treatment with only one prior chemotherapy regimen (including adjuvant therapy) ? Prior surgery and/or radiotherapy is permitted 7. Recovery from all acute toxic effects of prior chemotherapy, radiation therapy and surgery. The interval between completion of these treatments and enrollment into the trial should be at least 2 weeks 8. Males or females aged >/=18 years 9. ECOG performance status (PS) 0 or 1 10. Adequate organ function as determine by the following criteria: ? Absolute neutrophil count (ANC) >/= 1.5 x 10 000 000 000/L ? Platelet count >/=100 x 10 000 000 000/L ? Calculated creatinine clearance >/=45 mL/min using the standard Cockroft and Gault formula ? AST (SGOT) and ALT (SGPT) 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

1. Any histological/cytological evidence of small cell or carcinoid lung cancer 2. Uncontrolled pleural effusion (a controlled pleural effusion is defined as a basal effusion that is radiologically stable for at least 2 weeks). In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration 3. Known central nervous system (CNS) metastasis ? CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases 4. Prior neoadjuvant or adjuvant chemotherapy for NSCLC 5. Previous radiotherapy to the only site of measurable disease 6. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to: ? Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren?s syndrome, autoimmune thrombocytopenia or glomerulonephritis ? History of allogeneic transplant ? Untreated and/or uncontrolled superior vena cava syndrome ? Untreated and/or uncontrolled hypercalcemia ? Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of steroid inhalers, or oral ?physiologic replacement? doses of corticosteroids is permitted. Physiological replacement doses will be defined as CTCAE Grade 2 ? Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol 7. History of any active malignancy (other than NSCLC) during the last 3 years except non-melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level

Study & Design

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