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NCT02134015 · ClinicalTrials.gov registry record · Phase 3
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
A Phase 3 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
NCT02134015: Clinical Trial Phase 3 study, sponsored by Daiichi Sankyo.
NCT02134015 is a Phase 3 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 145 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
NCT02134015, a Phase 3 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
Study Summary
1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
Primary Outcome
PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG Patritumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-11-11 |
| Phase | Phase 3 |
Why NCT02134015 stopped before completion
NCT02134015 is an interventional study that assigns participants to a tested intervention. The registered 145 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 3 interventions - of which Placebo is the first listed.
NCT02134015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02134015 about?
NCT02134015 is a clinical study titled "Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)". 1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior sy...
What is the current status of trial NCT02134015?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2014-03. Estimated completion is 2016-11-11.
What interventions are being tested in trial NCT02134015?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), Patritumab (DRUG).
Who is sponsoring clinical trial NCT02134015?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02134015's enrollment target sits among peer trials
145 1555th of 2000 higher than 442 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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