Afatinib + Prednisone for Lung Cancer

Overseen by Sheena Bhalla

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: EGFR inhibitors, IMIDs, Anti-TNF

Disqualifiers: Symptomatic brain metastases, Uncontrolled diabetes, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have had systemic glucocorticoids (a type of steroid) within 3 weeks before starting the study. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drugs Afatinib and Prednisone for lung cancer?

While the provided research does not directly address Afatinib and Prednisone, it highlights the effectiveness of targeted therapies in lung cancer. Afatinib, a targeted therapy, may offer benefits similar to other targeted agents that have shown survival advantages in lung cancer treatment. ^{1 2 3 4 5}

What makes the drug combination of Afatinib and Prednisone unique for lung cancer treatment?

Afatinib is an oral drug that irreversibly blocks certain proteins involved in cancer growth, specifically targeting mutations in the epidermal growth factor receptor (EGFR), which makes it effective for certain types of lung cancer. Prednisone is a steroid that can help reduce inflammation and manage side effects. This combination may offer a novel approach by combining targeted cancer therapy with supportive care to improve patient outcomes. ^{6 7 8 9 10}

Research Team

Sheena Bhalla

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have enough tissue samples saved for further study.

Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.

You must have a measurable disease according to specific medical guidelines.

Exclusion Criteria

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

I am allergic to afatinib or prednisone.

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 Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Afatinib 40 mg PO daily and Prednisone 40 mg PO daily starting 7 days after Afatinib

60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Afatinib (Tyrosine Kinase Inhibitor)
• Prednisone (Corticosteroid)

Trial Overview 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.

Participant Groups

Group I: Afatinib + Prednisone Experimental Treatment 1 Intervention

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

Afatinib is already approved in Canada, Japan for the following indications:

Approved in Canada as Gilotrif for:

• Non-small cell lung cancer

Approved in Japan as Giotrif for:

• Non-small cell lung cancer

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

Cisplatin-based chemotherapy in the 1980s improved median survival for advanced non-small cell lung cancer (NSCLC) patients to about 7 months, compared to 4 months with best supportive care.

Newer drugs like vinorelbine, docetaxel, and gemcitabine have shown even better results, with median survivals over 7 months, and combinations with cisplatin have achieved median survivals of 10 months, suggesting potential for improved outcomes in advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do newer chemotherapeutic agents improve survival in non-small cell lung cancer? Rigas, JR.[2022]

Afatinib is an irreversible inhibitor of the ErbB family of tyrosine kinases, specifically approved for treating advanced non-small-cell lung cancer in adults with EGFR mutations.

Ongoing research is exploring the efficacy of afatinib in treating other types of cancers, such as head and neck squamous cell carcinoma (HNSCC) and breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib. Wecker, H., Waller, CF.[2018]

Afatinib significantly prolongs progression-free survival (PFS) and time to treatment failure (TTF) in patients with advanced lung adenocarcinoma with activating EGFR mutations compared to gefitinib, although it does not improve overall survival (OS).

In second-line treatment for advanced squamous non-small cell lung cancer (NSCLC), afatinib shows significant improvements in both PFS and OS compared to erlotinib, demonstrating its efficacy across different lung cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib: A Review in Advanced Non-Small Cell Lung Cancer. Keating, GM.[2018]

In a study of 10 elderly patients with advanced refractory non-small-cell lung cancer (NSCLC) and low performance status, afatinib was found to be tolerable, with a median overall survival of 5.8 months despite a low objective response rate of 11%.

The most common side effect was grade 2 diarrhea, which led to some patients refusing to increase the dosage, suggesting that a lower starting dose of afatinib may be a safer option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and efficacy of afatinib at a low starting dosage in 10 elderly or low performance status patients with advanced refractory non-small-cell lung cancer. Kashiwabara, K., Semba, H., Fujii, S., et al.[2018]

Afatinib is an effective first-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations, showing improved progression-free survival (PFS) compared to gefitinib and cisplatin-based chemotherapy, although it did not extend overall survival (OS) for all patients.

As a second-line treatment for advanced squamous NSCLC, afatinib significantly prolonged both PFS and OS compared to erlotinib, demonstrating its efficacy regardless of EGFR mutation status, and it has a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib in advanced NSCLC: a profile of its use. Deeks, ED., Keating, GM.[2020]

Afatinib is an effective oral treatment for adults with advanced non-small cell lung cancer (NSCLC) who have specific activating EGFR mutations, showing significantly prolonged progression-free survival compared to standard chemotherapy regimens in two phase III trials.

The drug has a manageable safety profile, with common side effects like diarrhea and rash being effectively controlled through dose adjustments, making it a valuable option for treatment-naïve patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib: a review of its use in the treatment of advanced non-small cell lung cancer. Keating, GM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

First-line treatment for advanced non-small-cell lung cancer. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Long term analysis of survival in the European randomized trial comparing vinorelbine/cisplatin to vindesine/cisplatin and vinorelbine alone in advanced non-small cell lung cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Role of Chemotherapy and Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical effectiveness of first-line chemotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Do newer chemotherapeutic agents improve survival in non-small cell lung cancer? [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Afatinib. [2018]

7. France pubmed.ncbi.nlm.nih.gov

Afatinib: A Review in Advanced Non-Small Cell Lung Cancer. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Tolerability and efficacy of afatinib at a low starting dosage in 10 elderly or low performance status patients with advanced refractory non-small-cell lung cancer. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Afatinib in advanced NSCLC: a profile of its use. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Afatinib: a review of its use in the treatment of advanced non-small cell lung cancer. [2022]