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NCT04552535 · ClinicalTrials.gov registry record
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung
A clinical trial of Squamous Non-Small Cell Lung Cancer, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT04552535: Completed study of Squamous Non-Small Cell Lung Cancer, sponsored by Boehringer Ingelheim.
NCT04552535 is a study of Squamous Non-Small Cell Lung Cancer that has completed, run by Boehringer Ingelheim. The registered enrollment target is 200 participants, below the 227-participant average among 6 other Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04552535, a study of Squamous Non-Small Cell Lung Cancer, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.
Primary Outcome
Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on t
Conditions Studied
Interventions
- DRUG Second line (2L) afatinib
- DRUG Second line chemotherapy
Study Locations (1)
Ohio
- Cardinal Health Specialty Solutions - Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-05-08 |
| Est. Completion | 2020-05-18 |
What the finished NCT04552535 record still lists
NCT04552535 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 227-participant average among 6 other Squamous Non-Small Cell Lung Cancer trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Squamous Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Second line (2L) afatinib is the first listed.
NCT04552535 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04552535 about?
NCT04552535 is a clinical study titled "A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung". This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.
What is the current status of trial NCT04552535?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2020-05-08. Estimated completion is 2020-05-18.
What conditions does trial NCT04552535 study?
This clinical trial studies the following conditions: Squamous Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04552535?
The interventions under investigation include: Second line (2L) afatinib (DRUG), Second line chemotherapy (DRUG).
Who is sponsoring clinical trial NCT04552535?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04552535 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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