Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

Phase 3

Terminated

Interventions: Drug: Cisplatin, Docetaxel
Drug: Gemcitabine, Cisplatin
Drug: Docetaxel, Cisplatin
Drug: Docetaxel

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
A: Control	Cisplatin, Docetaxel	Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
B1: Experimental group B1	Gemcitabine, Cisplatin	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
B2: Experimental group B2	Docetaxel, Cisplatin	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
B3: Experimental group B3	Docetaxel	Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From the date of start of the treatment until death or end of follow up, up to 18 months.	Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.

Locations (44): H. Virgen de los Lirios
🇪🇸
Alcoi, 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
🇪🇸
Cordoba, Córdoba, Spain
F.H.Alcorcón
🇪🇸
Alcorcon, Madrid, Spain
H. Severo Ochoa
🇪🇸
Leganés, Madrid, Spain
Clinica Quiron
🇪🇸
Pozuelo De Alarcón, Madrid, Spain
Hospital Universitario Quirón Madrid
🇪🇸
Pozuelo De Alarcón, Madrid, Spain
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H. Virgen de los Lirios
🇪🇸Alcoi, Alicante, Spain