SNPMiner Trials by Shray Alag


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Report for Mutation S1900D

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 A Randomized Phase II Study of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel Versus Standard of Care in Patients With Previously - Treated NFE2L2 or KEAP1-Positive Stage IV or Recurrent Squamous Cell Lung Cancer (ECOG-ACRIN LUNG-MAP Sub-Study)

This phase II LUNG-MAP treatment trial studies how well sapanisertib and docetaxel work for the treatment for squamous cell lung cancer that is stage IV or has come back (recurrent). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sapanisertib and docetaxel may work better in treating patients with squamous cell lung cancer compared to standard chemotherapy.

NCT04267913 Lung Squamous Cell Carcinoma Recurrent Lung Carcinoma Stage IV Lung C Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Drug: Dexamethasone Drug: Docetaxel Biological: Ramucirumab Drug: Sapanisertib
MeSH:Carcinoma Lung Neoplasms
HPO:Carcinoma Neoplasm of the lung

Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model adjusting for the stratification factors.. Inclusion Criteria: - Patients must be assigned to S1900D. --- S1900D ---

Assignment to S1900D is determined by the S1400 or LUNGMAP protocol genomic profiling using the FoundationOne assay. --- S1900D ---

Biomarker eligibility for S1900D is based on the identification of an NFE2L2 mutation or KEAP1 alteration - Patients must have a histologically or cytologically confirmed stage IV or recurrent pure squamous cell lung cancer - Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). --- S1900D ---

However, if at any point a previously celibate patient 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: - Patients must be assigned to S1900D. --- S1900D ---

Primary Outcomes

Description: IA-PFS will be compared between the arms using a stratified log-rank test.

Measure: Investigator-assessed progression-free survival (IA-PFS)

Time: Up to 3 years

Secondary Outcomes

Description: Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Measure: Overall response rate (ORR)

Time: Up to 3 years

Description: Will be estimated using the Kaplan-Meier method. The Brookmeyer-Crowley method will be used to estimate 95% confidence intervals for the median. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model adjusting for the stratification factors.

Measure: Duration of response

Time: Up to 3 years

Description: Will be estimated using the Kaplan-Meier method. The Brookmeyer-Crowley method will be used to estimate 95% confidence intervals for the median. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model adjusting for the stratification factors.

Measure: Progression free survival

Time: Up to 3 years

Description: Will be estimated using the Kaplan-Meier method. The Brookmeyer-Crowley method will be used to estimate 95% confidence intervals for the median. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model adjusting for the stratification factors.

Measure: Overall survival

Time: Up to 3 years


HPO Nodes