The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
Name: Rociletinib
Allocation: N/A
Single Group Assignment
There is one SNP
Inclusion Criteria - Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC - Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion - Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI - EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib - The washout period for an EGFR inhibitor is a minimum of 3 days - No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib - Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent) - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less - Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. --- T790M ---
Inclusion Criteria - Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC - Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion - Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI - EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib - The washout period for an EGFR inhibitor is a minimum of 3 days - No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib - Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent) - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less - Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. --- T790M --- --- T790M ---
- Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib - Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib - Prior treatment with rociletinib, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR - Any of the following cardiac abnormalities or history - Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) greater than 450 msec - Inability to measure QT interval on ECG - Personal or family history of long QT syndrome - Implantable pacemaker or implantable cardioverter defibrillator - Resting bradycardia less than 55 beats/min - Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib. --- T790M ---
In all cases, the patient must be sufficiently recovered and stable before treatment administration - Females who are pregnant or breastfeeding - Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study - Any other reason the investigator considers the patient should not participate in the study Inclusion Criteria - Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC - Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion - Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI - EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib - The washout period for an EGFR inhibitor is a minimum of 3 days - No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib - Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent) - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less - Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. --- T790M ---
In all cases, the patient must be sufficiently recovered and stable before treatment administration - Females who are pregnant or breastfeeding - Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study - Any other reason the investigator considers the patient should not participate in the study Inclusion Criteria - Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC - Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion - Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI - EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib - The washout period for an EGFR inhibitor is a minimum of 3 days - No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib - Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent) - Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less - Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. --- T790M --- --- T790M ---
Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. --- T790M ---
Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative. --- T790M ---
Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative. --- T790M --- --- T790M ---