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NCT02322281 · ClinicalTrials.gov registry record · Phase 3
TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
A Phase 3 study, sponsored by Clovis Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT02322281: Clinical Trial Phase 3 study, sponsored by Clovis Oncology.
NCT02322281 is a Phase 3 study that was terminated before completion, run by Clovis Oncology. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02322281, a Phase 3 study, was terminated before completion, sponsored by Clovis Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy.
Primary Outcome
PFS was calculated as 1+ the number of days from the date of randomization to documented radiographic progression as determined by the investigator, or death due to any cause, whichever occurs first. 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 addit
Interventions
- DRUG Rociletinib
- DRUG Pemetrexed or gemcitabine or paclitaxel or docetaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-03-29 |
| Phase | Phase 3 |
Why NCT02322281 stopped before completion
NCT02322281 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Rociletinib is the first listed.
NCT02322281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02322281 about?
NCT02322281 is a clinical study titled "TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy". The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-dir...
What is the current status of trial NCT02322281?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2015-02. Estimated completion is 2018-03-29.
What interventions are being tested in trial NCT02322281?
The interventions under investigation include: Rociletinib (DRUG), Pemetrexed or gemcitabine or paclitaxel or docetaxel (DRUG).
Who is sponsoring clinical trial NCT02322281?
This trial is sponsored by Clovis Oncology, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02322281's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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