Primary objective: · Progression free survival. Secondary objectives: * Assess Overall survival of both treatment groups. * Assess Tumor response rate using RECIST criteria * Assess Toxicity profile of patients enrolled in the study. * Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.
Study population: Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria). Duration of treatment: Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator. Calendar and planned finalization date: The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
382
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
Progression Free Survival
Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.
Overall Survival
Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.
Time frame: From the date of start of the treatment until death or end of follow up, up to 18 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
H. Virgen de los Lirios
Alcoy, Alicante, Spain
H. Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital D'Althaia
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital de Cruces
Barakaldo, Bizkaia, Spain
Hospital Reina Sofía
Córdoba, Córdoba, Spain
F.H.Alcorcón
Alcorcón, Madrid, Spain
H. Severo Ochoa
Leganés, Madrid, Spain
Clinica Quiron
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
...and 34 more locations