N/A
Completed N=200
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
Source: ClinicalTrials.gov NCT04552535 ↗Enrolled (actual)
200
Serious AEs
—
Results posted
Jul 2021
Primary outcomePrimary: Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment — 7.3; 4.2 months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment |
7.3; 4.2 | — |
| PRIMARY Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status |
5.8; 8.1 | — |
| PRIMARY Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status |
7.4; 5.9 | — |
| PRIMARY Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment |
6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of squamous or mixed histology non-small cell lung cancer
- Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV)
- First cycle of pembrolizumab received after 06/01/2018
- Permanently discontinued 1L pembrolizumab treatment
- Initiated second-line treatment at least 3 months prior to the date of data collection, with either :
- Afatinib
- Any chemotherapy
- Age ≥ 18 years
Exclusion Criteria
-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
Data sourced from ClinicalTrials.gov (NCT04552535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.