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Report for Clinical Trial NCT02147990

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)

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.

NCT02147990 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Rociletinib

Description: Rociletinib will be administered to patients orally
Type: Drug
Group Labels: 1

Rociletinib Mono-Therapy


Primary Outcomes

Measure: Objective Response rate (ORR) according to RECIST Version 1.1 as determined by independent radiology review (IRR).

Time: Every 8 weeks until disease progression, up to approximately 24 months

Secondary Outcomes

Measure: Duration of Response (DR), Disease Control Rate (DCR) and Progression Free Survival (PFS) according to RECIST Version 1.1 as determined by IRR

Time: Every 8 weeks until disease progression, up to approximately 24 months

Measure: Objective Response Rate (ORR), Duration of Response (DR), Progression Free Survival (PFS), Disease Control Rate (DCR) as determined by Investigator Assessment

Time: Every 8 weeks until disease progression, up to approximately 24 months

Measure: Overall Survival

Time: Every 4-8 weeks until date of death, up to approximately 60 months

Measure: Change from baseline in patient reported outcomes using EORTC QLQ C30, EORTC Quality of Life Questionnaire Lung Cancer module (EORTC QLQ LC13), and the Dermatology Life Quality Index (DLQI)

Time: Every 8-12 weeks until disease progression, up to approximately 24 months

Measure: Treatment emergent adverse events (AEs), laboratory abnormalities and ECG abnormalities

Time: Every 4 weeks until treatment discontinuation, up to approximately 24 months

Measure: Plasma PK parameters for rociletinib based on sparse sampling

Time: Every 4 weeks for approximately 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes


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