New drug cocktail shows promise for tough lung cancer
NCT ID NCT04497584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether combining two drugs, afatinib and prednisone, can help people with advanced squamous non-small cell lung cancer who have already tried other treatments. The goal was to see if the combination could slow cancer growth. The trial enrolled 12 adults and measured how long they lived without the cancer getting worse.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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12 people
The number who actually took part.
- Started
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Aug 2021
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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Other studies related to the condition(s) this trial covers.
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