Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03087448 · ClinicalTrials.gov registry record · Phase 1
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03087448: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT03087448 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03087448, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor) naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK tyrosine kinase inhibitor (TKI) patients.
Primary Outcome
Determine the maximum tolerated dose (MTD) by evaluating the number and frequency of Adverse Events (AEs) as determined by National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0 by investigator assessment, and identify a recommended phase II dose (RP2D) for phase II dose expansion cohorts.
Interventions
- DRUG Trametinib
- DRUG Ceritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-09-09 |
| Est. Completion | 2022-04-30 |
| Phase | Phase 1 |
Why NCT03087448 stopped before completion
NCT03087448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT03087448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03087448 about?
NCT03087448 is a clinical study titled "Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)". This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC....
What is the current status of trial NCT03087448?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2017-09-09. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT03087448?
The interventions under investigation include: Trametinib (DRUG), Ceritinib (DRUG).
Who is sponsoring clinical trial NCT03087448?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03087448's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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 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