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Report for Clinical Trial NCT04267913

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:Carcinoma Lung Neoplasms
HPO:Carcinoma Neoplasm of the lung

4 Interventions

Name: Dexamethasone

Description: Given IV
Type: Drug
Group Labels: 2

Arm A (docetaxel, dexamethasone, sapanisertib) Arm B (standard of care treatment)

Name: Docetaxel

Description: Given IV
Type: Drug
Group Labels: 2

Arm A (docetaxel, dexamethasone, sapanisertib) Arm B (standard of care treatment)

Name: Ramucirumab

Description: Given IV
Type: Biological
Group Labels: 1

Arm B (standard of care treatment)

Name: Sapanisertib

Description: Given PO
Type: Drug
Group Labels: 2

Arm A (docetaxel, dexamethasone, sapanisertib) Arm B (standard of care treatment)


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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 S1900D

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 ---


2 T790M

These cases should be discussed with a study chair prior to enrollment - Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) Exclusion Criteria: - Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy - Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to sub-study randomization, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to sub-study randomization. --- T790M ---


3 V600E

These cases should be discussed with a study chair prior to enrollment - Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) Exclusion Criteria: - Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy - Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to sub-study randomization, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 14 days prior to sub-study randomization. --- T790M --- --- V600E ---



HPO Nodes


HPO: