SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation L8585R

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 A Phase II Study of Epigenetic Therapy With Azacitidine and Entinostat With Concurrent Nivolumab in Subjects With Metastatic Non-Small Cell Lung Cancer.

Response Rate

NCT01928576
Conditions
  1. Non-Small Cell Lung Cancer
  2. Epigenetic Therapy
Interventions
  1. Drug: Azacitidine
  2. Drug: Entinostat
  3. Drug: Nivolumab
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

- All adenocarcinoma patients must be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with EGFR or ALK TKI therapy if found to have an actionable alteration. --- L8585R ---

Primary Outcomes

Description: Percentage of participants with response to combination Nivolumab and epigenetic therapy. Response will be assessed by RECIST 1.1 criteria, where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

Measure: Objective Response

Time: 2 years

Secondary Outcomes

Description: Number of months from the time of randomization until radiologic (per RECIST 1.1) or clinical progression or death, whichever comes first.

Measure: Progression free survival

Time: 2 years

Description: Number of months from the time nivolumab begins until radiologic (per RECIST 1.1) or clinical progression is noted.

Measure: Time to Progression

Time: 2 years

Description: Number of months from the time of randomization until death. Estimation will be by the Kaplan-Meier method.

Measure: Overall survival

Time: 2 years

Description: Number of participants who experience adverse events as defined by CTCAE v4.0.

Measure: Safety and tolerability as assessed by number of participants with adverse events

Time: 2 years

2 Randomized Phase II Trial of Local Consolidation Therapy (LCT) After Osimertinib for Patients With EGFR Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)

This phase II trial studies how well osimertinib, surgery, and radiation therapy work in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving osimertinib, surgery, and radiation therapy may work better at treating non-small cell lung cancer with EGFR mutations.

NCT03410043
Conditions
  1. EGFR Exon 19 Deletion Mutation
  2. EGFR NP_005219.2:p.L858R
  3. EGFR NP_005219.2:p.T790M
  4. Lung Non-Small Cell Carcinoma
  5. Recurrent Lung Non-Small Cell Carcinoma
  6. Stage IIIB Lung Cancer AJCC v8
  7. Stage IV Lung Cancer AJCC v8
  8. Stage IVA Lung Cancer AJCC v8
  9. Stage IVB Lung Cancer AJCC v8
Interventions
  1. Drug: Osimertinib
  2. Radiation: Radiation Therapy
  3. Procedure: Therapeutic Conventional Surgery
MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma

To determine whether osimertinib plus LCT improves progression-free survival compared with osimertinib alone in TKI naive EGFR (L8585R/exon 19 deletion) mutant metastatic NSCLC. --- L8585R ---

Primary Outcomes

Description: Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

Measure: Progression free survival (PFS)

Time: From the start date of osimertinib assessed up to 4 years

Secondary Outcomes

Description: Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

Measure: Overall survival

Time: From the treatment start date assessed up to 4 years

Description: Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

Measure: Time to progression of target lesions

Time: Up to 4 years

Description: Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

Measure: Time to appearance of new metastases

Time: Up to 4 years

Description: Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

Measure: PFS in oligometastatic subgroup

Time: Up to 4 years

Description: Toxicity data related to the treatments will be summarized by frequency tables. The association between the types and severity of toxicity and the treatment groups will be evaluated.

Measure: Incidence of adverse events

Time: Up to 30 days post treatment


HPO Nodes