Description:
To determine the efficacy of combined afatinib and prednisone in previously treated advanced
squamous NSCLC
Title
- Brief Title: Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC
- Official Title: An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
STU-2020-0509
- NCT ID:
NCT04497584
Conditions
- Advanced Squamous Non Small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Afatinib + Prednisone | | Afatinib + Prednisone |
Purpose
To determine the efficacy of combined afatinib and prednisone in previously treated advanced
squamous NSCLC
Detailed Description
This two-stage phase 2 study will determine the safety, tolerability, recommended phase 2
dose/maximum tolerated dose, preliminary efficacy and predictive/pharmacodynamic biomarkers
of combined EGFR inhibition (afatinib) and TNF inhibition (prednisone) in previously treated
NSCLC.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Afatinib + Prednisone | Experimental | Afatinib 40 mg PO daily
Prednisone 40 mg PO daily starting 7 days after Afatinib | |
Eligibility Criteria
Inclusion Criteria:
- Written informed consent in accordance with federal, local, and institutional
guidelines. The patient must provide informed consent prior to the first screening
procedure.
- Previously treated (up to three prior lines of therapy), histologically proven
advanced squamous NSCLC.
- No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or
anti-TNF antibodies.
- No treatment with systemic glucocorticoids within 3 weeks of initiation of study
therapy (topical and inhaled glucocorticoids are permitted).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,000/μL
- platelets ≥ 50,000/μl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
- CrCl ≥ 45 ml/min
- For both male and female patients, effective methods of contraception must be used
throughout the study and for 3 months following the last dose of study treatment.
- Adequate archival tissue (5-10 slides) for correlative studies.
- Subject must have measurable disease per RECIST 1.1
Exclusion Criteria:
- Chemotherapy, radiotherapy, or other cancer therapy within two weeks prior to starting
study treatment. Subjects must have recovered from prior treatment-related to
toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities
requiring ongoing medical management, such as hypothyroidism from prior immune
checkpoint inhibitor treatment).
- Subjects may not be receiving any other investigational agents for the treatment of
the cancer under study.
- Symptomatic brain metastases or brain metastases requiring escalating doses of
corticosteroids
- History of hypersensitivity or allergic reactions attributed to afatinib or
prednisone.
- Uncontrolled intercurrent illness including but not limited to poorly controlled
diabetes (which may worsen in setting of chronic prednisone therapy), symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that, in the opinion of the investigator, would limit
compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression-free survival of combined afatinib and prednisone in previously treated NSCLC |
| Time Frame: | From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months |
| Safety Issue: | |
| Description: | Measure progression-free survival rate. |
Secondary Outcome Measures
| Measure: | Response rate of combined afatinib and prednisone in previously treated NSCLC |
| Time Frame: | From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months |
| Safety Issue: | |
| Description: | Measure response rate by evaluation of target lesions by measuring disease. |
| Measure: | Overall survival of combined afatinib and prednisone in previously treated NSCLC |
| Time Frame: | From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months |
| Safety Issue: | |
| Description: | Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause. |
| Measure: | Safety of combined afatinib and prednisone in previously treated NSCLC |
| Time Frame: | From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months |
| Safety Issue: | |
| Description: | Measure risk to study participants by completing blood test and assessing according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | University of Texas Southwestern Medical Center |
Last Updated
July 20, 2021
