Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01827267 · ClinicalTrials.gov registry record · Phase 2
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Puma Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT01827267: Completed Phase 2 study, sponsored by Puma Biotechnology.
NCT01827267 is a Phase 2 study that has completed, run by Puma Biotechnology. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01827267, a Phase 2 study, has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.
Primary Outcome
ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.
Interventions
- DRUG temsirolimus
- DRUG neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-07-01 |
| Est. Completion | 2017-10-06 |
| Phase | Phase 2 |
What the finished NCT01827267 record still lists
NCT01827267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which temsirolimus is the first listed.
NCT01827267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01827267 about?
NCT01827267 is a clinical study titled "Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer". This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.
What is the current status of trial NCT01827267?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2013-07-01. Estimated completion is 2017-10-06.
What interventions are being tested in trial NCT01827267?
The interventions under investigation include: temsirolimus (DRUG), neratinib (DRUG).
Who is sponsoring clinical trial NCT01827267?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01827267's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03231150 · 62 participants · NA
Plantar Fasciitis Randomized Clinical Control Trial
- NCT03458676 · 62 participants · NA
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
- NCT03596086 · 62 participants · Phase 1
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
- NCT03603405 · 62 participants · Phase 1
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI