A factorial study comparing pemetrexed with gemcitabine and testing the efficacy of the addition of cisplatin in elderly patients with non squamous advanced, metastatic or recurrent NSCLC.
- Conditions
- elderly patients with non squamous advanced, metastatic or recurrent NSCLCMedDRA version: 14.1Level: PTClassification code 10025038Term: Lung adenocarcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10023780Term: Large cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000164-25-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
· Diagnosis of cytologically or histologically confirmed non-small cell lung cancer. · Non squamous tumor type (including those with a non-specified tumor type). · Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition. · 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 version 1.1. · Male or female ³ 70 years of age. · ECOG PS 0 or 1. · Life expectancy of > 3 months. · Neutrophils ³ 1.5 x 109/L, platelets ³ 100 x 109/L, and hemoglobin ³ 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. · Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
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 550
· Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy. · 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 with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed). · Known or suspected hypersensitivity to any of the study drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test whether the addition of cisplatin to single agent chemotherapy (gemcitabine or pemetrexed) prolongs survival as compared to single agent chemotherapy in elderly patients with non squamous NSCLC. To test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.;Secondary Objective: To compare toxicity within each planned comparison. To compare progression-free survival within each planned comparison. To compare response rate within each planned comparison. To compare quality of life within each planned comparison. To conduct exploratory analyses for the identification of prognostic and predictive factors of the efficacy of pemetrexed and cisplatin;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: Every 3 weeks in the treatment; every 12 weeks last treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): toxicity; progression-free survival; response rate; quality of life.;Timepoint(s) of evaluation of this end point: Every 3 weeks in the treatment; every 12 weeks last treatment