There are 2 clinical trials
Response Rate
All adenocarcinoma patients will be tested for ALK rearrangements and EGFR (Exon 19 Deletion and Exon 21 L8585R Substitution) mutations and must have been treated with prior EGFR or ALK therapy as well as a platinum containing doublet. --- L8585R ---
Description: Being progression-free at 32 weeks after randomization. Response will be assessed from baseline scans at randomization (i.e., within 4 weeks prior to starting epigenetic therapy).
Measure: Response Time: 32 weeksDescription: Progression-free survival (overall) will be measured from the time of randomizationuntil radiologic or clinical progression is noted. Estimation will be by the Kaplan-Meier method.
Measure: Progression free survival Time: 2 yearsDescription: Time to progression (nivolumab) on nivolumab will be measured from the time nivolumab begins until radiologic or clinical progression is noted. Estimation will be by the Kaplan-Meier method.
Measure: Time to Progression Time: 2 yearsDescription: Overall survival will be measured from the time of randomization until death. Estimation will be by the Kaplan-Meier method.
Measure: Overall survival Time: 2 yearsDescription: Toxicities observed in both phases of the study will be assessed by CTCAE 4.0 criteria. We will tabulate toxicities and compare the two treatment groups via methods appropriate for categorical data.
Measure: Safety and tolerability Time: 2 yearsThis 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.
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 ---
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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