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Report for Mutation S1400E
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
S1400E (CLOSED TO ACCRUAL 11/25/2014): Patients with tumors positive for met proto-oncogene (MET) are randomized to 1 of 2 treatment arms. --- S1400E ---
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/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-Met Positive Patients With Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
This randomized phase II/III compares rilotumumab when given together with erlotinib hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in treating squamous cell lung cancer.
NCT02926638 MET Positive Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Drug: Erlotinib Hydrochloride Other: Laboratory Biomarker Analysis Biological: Rilotumumab MeSH:Carcinoma Lung Neoplasms
HPO:Carcinoma Neoplasm of the lung
Monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to.. Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows: - Analyte: C-MET - Assay: Immunohistochemistry (IHC) - Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit - If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing - Patients must not have peripheral edema > grade 1 at the time of sub-study registration - Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib) - Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration - Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s --- S1400E ---
Monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to.. Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows: - Analyte: C-MET - Assay: Immunohistochemistry (IHC) - Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit - If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing - Patients must not have peripheral edema > grade 1 at the time of sub-study registration - Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib) - Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration - Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s --- S1400E --- --- S1400E ---
syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test) - Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows: - Analyte: C-MET - Assay: Immunohistochemistry (IHC) - Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit - If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing - Patients must not have peripheral edema > grade 1 at the time of sub-study registration - Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib) - Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration - Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s --- S1400E ---
syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test) - Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows: - Analyte: C-MET - Assay: Immunohistochemistry (IHC) - Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit - If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing - Patients must not have peripheral edema > grade 1 at the time of sub-study registration - Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib) - Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration - Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s --- S1400E --- --- S1400E ---
syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test) - Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates MET Positive Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Carcinoma Lung Neoplasms PRIMARY OBJECTIVES: I. To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival (IA-PFS) between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E. --- S1400E ---
syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test) - Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates MET Positive Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Carcinoma Lung Neoplasms PRIMARY OBJECTIVES: I. To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival (IA-PFS) between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E. --- S1400E --- --- S1400E ---
(Phase III) TERTIARY OBJECTIVES: I. To evaluate the treatment arm randomization acceptance rate within each treatment arm of S1400E defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment. --- S1400E ---
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 Between Arms 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 accrualMeasure: Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) Between Arms Time: Up to 3 years
Secondary Outcomes
Measure: Frequency and Severity of Toxicities Associated With Investigational Therapy Versus Standard of Care Time: Up to 3 yearsOther Outcomes
Description: Monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to.
Measure: Treatment Arm Randomization Acceptance Rate Time: Up to 3 years