What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) like Afatinib (a Tyrosine Kinase Inhibitor) and Prednisone (a corticosteroid) have distinct side effect profiles. Afatinib often causes diarrhea, rash, stomatitis, and paronychia, with serious risks including interstitial lung disease and liver toxicity. Prednisone can lead to increased blood sugar, weight gain, hypertension, mood swings, and a higher risk of infections. Long-term use of Prednisone may result in osteoporosis, adrenal suppression, and muscle weakness.

What prior FDA approvals exist?

Several Tyrosine Kinase Inhibitors (TKIs) have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Erlotinib, an EGFR TKI, has shown improvement in progression-free survival (PFS) and overall survival (OS) in patients with activating EGFR mutations. Osimertinib, another EGFR TKI, is approved for adjuvant therapy in resected EGFR-mutant NSCLC due to its efficacy in reducing CNS relapses. Additionally, sotorasib and adagrasib are approved for KRAS G12C-mutated NSCLC. While corticosteroids like Prednisone are commonly used to manage symptoms and reduce inflammation, they are not typically the primary treatment for NSCLC but may be used adjunctively.

What other types of research exist?

Promising novel alternatives to Afatinib and Prednisone for NSCLC patients include: 1) Pembrolizumab (an anti-PD-1 therapy) combined with chemotherapy, as shown in the KEYNOTE-189 trial, which demonstrated improved survival outcomes. 2) Atezolizumab (an anti-PD-L1 therapy) combined with bevacizumab and chemotherapy, as evidenced by the IMpower150 trial, which showed efficacy in patients with specific mutations and baseline liver metastases. 3) Trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) for patients with HER2 mutations, approved by the FDA for those who have received prior systemic therapy. These alternatives offer targeted and immunotherapy options that have shown promising results in recent studies.

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Tyrosine Kinase Inhibitor

Afatinib + Prednisone for Lung Cancer

Phase 2

Recruiting

Led By David Gerber, 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.

Must not have

Symptomatic brain metastases or brain metastases requiring escalating doses of corticosteroids

History of hypersensitivity or allergic reactions attributed to afatinib or prednisone.

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

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, afatinib and prednisone, for patients with advanced squamous non-small cell lung cancer. Afatinib aims to stop cancer growth by targeting specific proteins, while prednisone helps reduce inflammation and immune reactions. The goal is to find out if this combination is safe and effective for these patients. Afatinib has been shown to be effective as a follow-up treatment for advanced lung squamous cell carcinoma and has benefits in combination with other therapies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are causing symptoms or need more steroids.

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I am allergic to afatinib or prednisone.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include Tyrosine Kinase Inhibitors (TKIs) and corticosteroids. TKIs, such as Afatinib, target specific proteins involved in the growth and spread of cancer cells, particularly the ErbB family of receptors, which includes EGFR. By inhibiting these receptors, TKIs can effectively slow down or stop the proliferation of cancer cells. Corticosteroids like Prednisone reduce inflammation and modulate the immune response, which can help alleviate symptoms and improve the quality of life for patients. These treatments are crucial for NSCLC patients as they offer targeted and symptomatic relief, potentially leading to better outcomes and prolonged survival.