TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy (EGFR)
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|ClinicalTrials.gov Identifier: NCT02186301|
Recruitment Status : Terminated (Sponsor discontinued development of CO-1686 for NSCLC)
First Posted : July 10, 2014
Results First Posted : April 30, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Rociletinib Mono-Therapy Drug: Erlotinib Mono-Therapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 28, 2017|
|Actual Study Completion Date :||June 28, 2017|
|Active Comparator: Erlotinib Mono-Therapy||
Drug: Erlotinib Mono-Therapy
Erlotinib will be administered once a day
|Experimental: Rociletinib Mono-Therapy||
Drug: Rociletinib Mono-Therapy
Rociletinib will be administered twice daily
- Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS) [ Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months ]To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
- Confirmed Response Rate [ Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. ]
Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as:
Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.
- Duration of Response [ Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months ]Duration of Response in Patients with Confirmed Response per Investigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186301
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