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NCT03157089 · ClinicalTrials.gov registry record · Phase 2
Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03157089: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03157089 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03157089, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment. The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.
Primary Outcome
Objective response rate is defined as percentage of participants with the best overall response of complete response (CR, disappearance of all target lesions) or confirmed partial response (PR, at least a 30% decrease in sum of diameter (SoD, longest diameter (LD) measured for all lesions except lymph nodes, where shortest diameter (ShD) was used) of target lesions, reference is baseline SoD). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magneti
Interventions
- DRUG pembrolizumab
- DRUG Afatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-11-02 |
| Est. Completion | 2020-01-13 |
| Phase | Phase 2 |
What the finished NCT03157089 record still lists
NCT03157089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which pembrolizumab is the first listed.
NCT03157089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03157089 about?
NCT03157089 is a clinical study titled "Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung". The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment. The secondary objectives are to confi...
What is the current status of trial NCT03157089?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2017-11-02. Estimated completion is 2020-01-13.
What interventions are being tested in trial NCT03157089?
The interventions under investigation include: pembrolizumab (DRUG), Afatinib (DRUG).
Who is sponsoring clinical trial NCT03157089?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03157089's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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
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