Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

The University of Texas System (UT)

Status and phase

Active, not recruiting

Phase 2

Conditions

Advanced Squamous Non Small Cell Lung Cancer

Treatments

Drug: Afatinib + Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT04497584

STU-2020-1363

Details and patient eligibility

About

To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.