Advanced Squamous Non Small Cell Lung CancerPhase 2NCT04497584
Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC
A Phase 2 study testing Afatinib + Prednisone in people with Advanced Squamous Non Small Cell Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Squamous Non Small Cell Lung Cancer
- What is being tested?
- Afatinib + Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
To determine the efficacy of combined afatinib and prednisone in previously treated advanced squamous NSCLC
Read the 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.
- Being tested
- Afatinib + Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib + PrednisoneDrug
Afatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib + Prednisone | Experimental | Afatinib 40 mg PO daily
Prednisone 40 mg PO daily starting 7 days after Afatinib Receives: Drug: Afatinib + Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of combined afatinib and prednisone in previously treated NSCLC
Measure progression-free survival rate.
Measured: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (3)
Response rate of combined afatinib and prednisone in previously treated NSCLC
Measure response rate by evaluation of target lesions by measuring disease.
Measured: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Overall survival of combined afatinib and prednisone in previously treated NSCLC
Measure Overall Survival, as the time from the date of initiation of study treatment until death of any cause.
Measured: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Safety of combined afatinib and prednisone in previously treated NSCLC
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.
Measured: From date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start4 Aug 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Squamous Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheena Bhalla, University of Texas Southwestern Medical Center
- Investigators
- Sheena Bhalla, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497584
- Sponsor's protocol ID
- STU-2020-1363
- Status last verified
- Sep 2025
- First submitted
- 22 May 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04497584
- Acronym / sponsor ID
- STU-2020-1363
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Afatinib 40 mg PO daily Prednisone 40 mg PO daily (starting 7 days after afatinib)
| Arm | Type | Receives |
|---|---|---|
| Afatinib + Prednisone | Experimental | Drug: Afatinib + PrednisoneAfatinib 40 mg PO daily Prednisone 40 mg PO daily starting 7 days after Afatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib + PrednisoneAfatinib (40mg) will be taken by mouth daily starting on Cycle 1, Day -7. Prednisone (40mg) will be taken by mouth daily starting on Cycle 1, Day 1. | Drug | Afatinib + Prednisone |
Primary outcome
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
Measure progression-free survival rate.
3 secondary outcomes
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
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheena Bhalla, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib + Prednisone in people with Advanced Squamous Non Small Cell Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.