Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 382
- Locations
- 44
- Primary Endpoint
- Progression Free Survival
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A: Control
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Intervention: Cisplatin, Docetaxel (Drug)
B1: Experimental group B1
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
Intervention: Gemcitabine, Cisplatin (Drug)
B2: Experimental group B2
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
Intervention: Docetaxel, Cisplatin (Drug)
B3: Experimental group B3
Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Intervention: Docetaxel (Drug)
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 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 Outcomes
- Overall Survival(From the date of start of the treatment until death or end of follow up, up to 18 months.)