Conditions: Non Small Cell Lung Cancer BRCA1 Mutation
Keywords: Lung Cancer Chemotherapy Personalized medicine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 382
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 arm 2: Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 arm 3: Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 arm 4: Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Interventions: intervention 1: Cisplatin, Docetaxel intervention 2: Gemcitabine, Cisplatin intervention 3: Docetaxel, Cisplatin intervention 4: Docetaxel
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 intervention 2: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 intervention 3: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 intervention 4: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Protocol document: