SNPMiner Trials (Home Page)
Report for Mutation S1400F
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
NCT02154490 Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Drug: Docetaxel Biological: Durvalumab Drug: Erlotinib Hydrochloride Drug: FGFR Inhibitor AZD4547 Biological: Ipilimumab Other: Laboratory Biomarker Analysis Biological: Nivolumab Drug: Palbociclib Other: Pharmacological Study Biological: Rilotumumab Drug: Talazoparib Drug: Taselisib Biological: Tremelimumab MeSH:Carcinoma Lung Neoplasms
HPO:Carcinoma Neoplasm of the lung
S1400F: Patients with disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment receive durvalumab (IV over 60 minutes) and tremelimumab (IV over 60 minutes) on day 1 for courses 1-4 and durvalumab IV alone on day 1 of course 5 and subsequent courses until disease progression or unacceptable toxicity. --- S1400F ---
Primary Outcomes
Description: A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms.
Measure: Investigator-assessed progression-free survival as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II) 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 18 months since completion of accrualDescription: Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median investigator-assessed progression-free survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified.
Measure: Investigator-assessed progression-free survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy vs standard therapy (Design #2,Phase III,Option for Biomarker-driven sub-studies) Time: Up to 3 yearsDescription: A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
Measure: Less than 33% improvement in median investigator-assessed progression-free survival as defined as Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase III) 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 18 months since completion of accrualDescription: The investigational therapy arm will be judged to have provided sufficient evidence to proceed to the Phase III component if the objective response rate is at least 25%. Response rates and associated confidence intervals will be calculated.
Measure: Objective response rate (confirmed and unconfirmed, complete and partial) (Design #2, Phase II, Option for Biomarker-driven Sub-studies) Time: Up to 3 yearsDescription: Response rates and associated confidence intervals will be calculated.
Measure: Objective response rate (confirmed and unconfirmed, complete and partial) in patients treated with investigational non-match therapy with advanced stage refractory squamous cell carcinoma of the lung (Design #2, Option for Non-Match Sub-Studies) Time: Up to 3 yearsDescription: A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
Measure: Overall survival (Design #1, Phase III) Time: From date of sub-study registration (or date of screening registration if patient never enrolls in a sub-study) to date of death due to any cause, assessed up to 3 yearsDescription: The Brookmeyer-Crowley method will be used to calculate confidence intervals for median overall survival. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified.
Measure: Overall survival in patients with advanced stage refractory squamous cell carcinoma of the lung randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) Time: Up to 3 yearsSecondary Outcomes
Description: Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median duration of response.
Measure: Duration of response among patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) Time: Up to 3 yearsDescription: Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
Measure: Frequency and severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) Time: Up to 3 yearsDescription: Descriptive data will be presented.
Measure: Investigator-assessed progression-free survival, censoring patients with symptomatic deterioration at the time of symptomatic deterioration (Design #1, Phase III) 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: A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to overall survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
Measure: Overall survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) Time: Up to 3 yearsDescription: A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to progression free survival comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.
Measure: Progression free survival with investigational therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) Time: Up to 3 yearsDescription: Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate. Response proportions will be compared using a 1-sided Fisher?s exact test at the 0.001 level.
Measure: Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by Response Evaluation Criteria in Solid Tumors 1.1 (Design #1, Phase II and III) Time: Up to 3 yearsDescription: Analysis of response rates will be performed using a chi-square or Fisher?s exact test, as appropriate.
Measure: Response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus standard therapy (Design #2, Phase III, Option for Biomarker-driven Sub-studies) Time: Up to 3 yearsDescription: Analysis of toxicities will be performed using a chi-square or Fisher?s exact test, as appropriate.
Measure: Severity of toxicities associated with investigational therapy versus standard therapy (Design #2, Phase II, Option for Biomarker-driven Sub-studies and Design #2, Option for Non-Match Sub-studies) Time: Up to 3 yearsDescription: Analysis will be performed using a chi squared or Fisher?s exact test, as appropriate.
Measure: Toxicity frequencies, monitored using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Design #1, Phase II and III) Time: Up to 3 yearsOther Outcomes
Description: Descriptive data will be presented.
Measure: Screen success rate, monitored by the percentage of screened patients that register to a therapeutic sub-study Time: Up to 3 yearsDescription: Descriptive data will be presented.
Measure: Treatment arm randomization acceptance rate, monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to (Design #1) Time: Up to 3 years2 A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)
This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.
NCT03373760 Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Biological: Durvalumab Other: Laboratory Biomarker Analysis Biological: Tremelimumab MeSH:Carcinoma Lung Neoplasms
HPO:Carcinoma Neoplasm of the lung
The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS.. Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---
post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy - Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the durvalumab (MEDI4736) and/or tremelimumab formulation - Patients must not have clinical signs or symptoms of active tuberculosis infection - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed - Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior to sub-study registration - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---
Primary Outcomes
Description: Estimated within 13% with 95% confidence.
Measure: Objective response rate assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Time: Up to 3 yearsSecondary Outcomes
Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median DOR.
Measure: Duration of response (DOR) Time: Up to 3 yearsDescription: Will be estimated using the method of Kaplan-Meier.
Measure: Immune-Related Response Criteria investigator-assessed progression-free survival (irRC-IA-PFS) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Time: From date of registration to date of first documentation of irRC progression or death due to any cause, assessed up to 3 yearsDescription: Toxicity rates can be estimated within 13% with 95% confidence. Any toxicity with at least 5% prevalence has at least a 95% chance of being observed.
Measure: Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Time: 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 IA-PFS.
Measure: Investigator-assessed progression-free survival (IA-PFS) Time: 6 months after completion of accrualDescription: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS.
Measure: Overall survival (OS) Time: 6 months after completion of accrual