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)
|ClinicalTrials.gov Identifier: NCT02147990|
Recruitment Status : Active, not recruiting
First Posted : May 28, 2014
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Rociletinib||Phase 2|
This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.
Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. 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.
All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.
The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
|Experimental: Rociletinib Mono-Therapy||
Rociletinib will be administered to patients orally
Other Name: CO-1686
- Objective Response rate (ORR) according to RECIST Version 1.1 as determined by independent radiology review (IRR). [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]
- Duration of Response (DR), Disease Control Rate (DCR) and Progression Free Survival (PFS) according to RECIST Version 1.1 as determined by IRR [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]
- Objective Response Rate (ORR), Duration of Response (DR), Progression Free Survival (PFS), Disease Control Rate (DCR) as determined by Investigator Assessment [ Time Frame: Every 8 weeks until disease progression, up to approximately 24 months ]
- Overall Survival [ Time Frame: Every 4-8 weeks until date of death, up to approximately 60 months ]
- 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 Frame: Every 8-12 weeks until disease progression, up to approximately 24 months ]
- Treatment emergent adverse events (AEs), laboratory abnormalities and ECG abnormalities [ Time Frame: Every 4 weeks until treatment discontinuation, up to approximately 24 months ]
- Plasma PK parameters for rociletinib based on sparse sampling [ Time Frame: Every 4 weeks for approximately 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147990
Show 91 Study Locations