SNPMiner Trials (Home Page)
Report for Mutation S1900A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II Study of Rucaparib in Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT03845296 Deleterious BRCA1 Gene Mutation Deleterious BRCA2 Gene Mutation Loss of Heterozygosity Lung Non-Small Cell Squamous Carcinoma Recurrent Large Cell Lung Carcinoma Recurrent Lung Adenocarcinoma Recurrent Lung Non-Small Cell Carcinoma Recurrent Non-Squamous Non-Small Cell Lung Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Drug: Rucaparib MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma of Lung Carcinoma, Squamous Cell
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma Squamous cell carcinoma
Toxicity can be estimated to within 11% with 95% confidence.. Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1900A. --- S1900A ---
S1900A biomarker eligibility defined as LOH high and/or deleterious BRCA1/2 mutation is as follows using the Foundation Medicine Inc (FMI) tissue- assay: - LOH; alteration type: loss of heterozygosity (LOH); eligible alteration: Genomic LOH >= 21% - BRCA; alteration type: homologous recombination deficiency (HRD); eligible alteration: Deleterious mutations in BRCA1 or BRCA2 - Patients must not have had prior treatment with any PARP inhibitor, including rucaparib, talazoparib, veliparib, olaparib, or niraparib. --- S1900A ---
For information and a list of PARP inhibitors, please consult the S1900A ? --- S1900A ---
Poly Polymerase Inhibitors, Scott et al., 2015 JCO ref from the link on the S1900A protocol abstract page of the SWOG (http://swog.org) --- S1900A ---
Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1900A. --- S1900A ---
Primary Outcomes
Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: Investigator assessed progression free survival (PFS) Time: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsDescription: Response will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. Response rates and associated confidence intervals will be calculated. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times. Response rates can be estimated within 16% with 95% confidence.
Measure: Duration of response (DoR) Time: From date of first documentation of response (complete response [CR] or partial response [PR]) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: Overall survival Time: From date of sub-study registration to date of death due to any cause, assessed up to 3 yearsMeasure: Time to death Time: From date of sub-study registration to date of death due to any cause, assessed up to 3 years
Description: Toxicity will be evaluated among all patients enrolled on the study (combining the squamous and non-squamous cohorts). Toxicity can be estimated to within 11% with 95% confidence.
Measure: Incidence of adverse events Time: Up to 3 years