SNPMiner Trials by Shray Alag
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SNPMiner Trials (Home Page)
Report for Mutation S1900E
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells.
NCT04625647 Conditions
- Lung Adenocarcinoma
- Lung Non-Small Cell Carcinoma
- Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
Interventions
- Drug: Sotorasib
MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma of Lung
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma
With participants in Cohort 1 and 3 and participants in Cohort 2, binary proportions can be estimated to within 16% and 20% with 95% confidence, respectively.. Inclusion Criteria: - Participants must be assigned to S1900E. --- S1900E ---
Assignment to S1900E is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. --- S1900E ---
Biomarker eligibility for S1900E is based on the identification of a KRAS^G12C mutation - Participants must have confirmed stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). --- S1900E ---
However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures Inclusion Criteria: - Participants must be assigned to S1900E. --- S1900E ---
Primary Outcomes
Measure: Response rate (confirmed, complete or partial) Time: Up to 3 yearsSecondary Outcomes
Description: The frequency and grade of individual toxicities attributable to treatment will be estimated.
Measure: Incidence of adverse events Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method and about landmark time points will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Binary proportions and associated confidence intervals will be estimated for within cohort objectives. With participants in Cohort 1 and 3 and participants in Cohort 2, binary proportions can be estimated to within 16% and 20% with 95% confidence, respectively.
Measure: Progression free survival Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method and about landmark time points will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Binary proportions and associated confidence intervals will be estimated for within cohort objectives. With participants in Cohort 1 and 3 and participants in Cohort 2, binary proportions can be estimated to within 16% and 20% with 95% confidence, respectively.
Measure: Overall survival Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier. Confidence intervals about medians will be estimated using the Brookmeyer-Crowley method and about landmark time points will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Binary proportions and associated confidence intervals will be estimated for within cohort objectives. With participants in Cohort 1 and 3 and participants in Cohort 2, binary proportions can be estimated to within 16% and 20% with 95% confidence, respectively.
Measure: Duration of response Time: Up to 3 years