SNPMiner Trials by Shray Alag

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SNPMiner 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
  1. Lung Adenocarcinoma
  2. Lung Non-Small Cell Carcinoma
  3. Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
  4. Stage IV Lung Cancer AJCC v8
  5. Stage IVA Lung Cancer AJCC v8
  6. Stage IVB Lung Cancer AJCC v8
Interventions
  1. 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 years

Secondary Outcomes

Description: The frequency and grade of individual toxicities attributable to treatment will be estimated.

Measure: Incidence of adverse events

Time: Up to 3 years

Description: 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 years

Description: 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 years

Description: 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


HPO Nodes