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Tyrosine Kinase Inhibitor

Afatinib + Prednisone for Lung Cancer

Phase 2

Recruiting

Led By Sheena Bhalla, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment with EGFR inhibitors, IMIDs (eg, thalidomide, lenalidomide), or anti-TNF antibodies.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

Awards & highlights

Study Summary

This trial sought to find out if adding afatinib to prednisone treatment for advanced squamous non-small cell lung cancer (NSCLC) would be more effective than just prednisone alone.

Who is the study for?

Adults over 18 with advanced squamous NSCLC who've had up to three prior treatments can join. They must not have used systemic steroids recently, EGFR inhibitors, IMIDs, or anti-TNF antibodies. Participants need measurable disease per RECIST 1.1 and good organ/marrow function. No pregnant/nursing individuals or those with certain health issues like uncontrolled diabetes or symptomatic brain metastases.Check my eligibility

What is being tested?

The trial tests the effectiveness of afatinib combined with prednisone in patients who have previously treated advanced squamous NSCLC. It aims to see if this combination helps control cancer better than previous therapies they've received.See study design

What are the potential side effects?

Afatinib may cause diarrhea, rash, mouth sores, nail inflammation, and decreased appetite; while prednisone can lead to weight gain, mood swings, increased blood sugar levels (especially important for diabetics), insomnia and weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not been treated with EGFR inhibitors, IMIDs, or anti-TNF antibodies.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood counts and liver/kidney functions are within normal ranges.

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I haven't taken any steroid pills or injections for 3 weeks.

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I am 18 years old or older.

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I have advanced squamous NSCLC and received up to three prior treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment to date of documented progression or death from any cause, whichever came first, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival of combined afatinib and prednisone in previously treated NSCLC

Secondary outcome measures

Overall survival of combined afatinib and prednisone in previously treated NSCLC

Response rate of combined afatinib and prednisone in previously treated NSCLC

Safety of combined afatinib and prednisone in previously treated NSCLC

Trial Design

1Treatment groups

Experimental Treatment

Group I: Afatinib + PrednisoneExperimental Treatment1 Intervention

Afatinib 40 mg PO daily Prednisone 40 mg PO daily starting 7 days after Afatinib

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,738 Total Patients Enrolled

Sheena Bhalla, MDPrincipal InvestigatorUT Southwestern Medical Center

David Gerber, MDPrincipal InvestigatorUT Southwestern Medical Center

5 Previous Clinical Trials

170 Total Patients Enrolled

Media Library

Afatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04497584 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Afatinib + Prednisone

Non-Small Cell Lung Cancer Clinical Trial 2023: Afatinib Highlights & Side Effects. Trial Name: NCT04497584 — Phase 2

Afatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497584 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what circumstances is the combined administration of Afatinib and Prednisone recommended?

"Afatinib + Prednisone can help individuals suffering from thyroiditis, malignant neoplasms, and ulcerative colitis manage their medical condition."

Answered by AI

Have prior research been conducted to explore the effects of Afatinib combined with Prednisone?

"At present, there are 365 active trials exploring the effectiveness of Afatinib + Prednisone therapy. 94 of these investigations have progressed to the third stage and 18462 medical centres around the world are running studies for this treatment combination. Notably, many of these clinical sites are located in Duarte, California."

Answered by AI

Has the Afatinib + Prednisone combination been certified by the FDA?

"Our team at Power deemed the safety of Afatinib + Prednisone to be a 2, as there is evidence of its security but not yet any research that confirms efficacy."

Answered by AI

Are individuals able to join this experiment presently?

"Affirmative. The clinical trial's listing on clinicialtrials.gov shows that it is still enrolling participants, with the first posting made in August 4th 2021 and edited as recently as June 28th 2022. 37 people from a single location are needed for this research endeavour."

Answered by AI

To what extent has recruitment for this trial been conducted?

"Affirmative. As per the information available on clinicaltrials.gov, this clinical trial is presently accepting participants. The study was first posted on August 4th 2021 and underwent its last update in June 28th 2022, seeking 37 patients from 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC

Sheena Bhalla 2021. "Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04497584.

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