Poziotinib for Advanced Non-Small Cell Lung Cancer

Overseen By Yasir Y. Elamin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

93 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well poziotinib works in treating patients with non-small lung cancer with an EGFR or HER2 exon 20 mutation that is stage IV or has come back (recurrent). Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth..

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who are receiving other cancer treatments or investigational drugs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Poziotinib for treating advanced non-small cell lung cancer?

Research shows that Poziotinib has been effective in treating non-small cell lung cancer with specific mutations, such as HER2 exon 20 mutations, and has shown activity against similar cancer types. It has been tested in various studies, demonstrating its potential to target cancer cells with certain genetic changes. ^{1 2 3 4 5}

Is Poziotinib safe for humans?

Poziotinib has been studied in various clinical trials for different cancers, including lung and gastric cancer. These studies have evaluated its safety, determining the maximum tolerated dose (the highest dose that does not cause unacceptable side effects) and monitoring for any adverse effects. While specific side effects are not detailed here, the trials indicate that safety has been a focus of research. ^{1 2 3 4 5}

How is the drug Poziotinib unique for treating advanced non-small cell lung cancer?

Poziotinib is unique because it is a pan-HER tyrosine kinase inhibitor that targets multiple receptors (EGFR, HER2, and HER4) and is particularly effective in patients with specific mutations like HER2 exon 20, which are not well-addressed by existing treatments. ^{1 2 3 4 5}

Research Team

Yasir Y. Elamin

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that has specific mutations (EGFR or HER2 exon 20). Participants must have tried all standard treatments, be able to swallow pills, and not be pregnant. They should also have adequate organ function and agree to use contraception.

Inclusion Criteria

My solid tumor, not lung cancer, has EGFR or HER2 mutations.

I have tried all standard treatments for my advanced cancer or cannot receive them.

You have a disease that can be measured using a specific medical guideline.

Exclusion Criteria

I am not using effective birth control.

I have a condition that causes me to bleed easily.

My cancer has a specific EGFR mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive poziotinib orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups at 30 days and then every 6 months.

Up to 4 years

Treatment Details

Interventions

• Poziotinib

Trial Overview The trial is testing the effectiveness of Poziotinib, a drug designed to block enzymes that promote tumor growth in patients with certain genetic mutations in their lung cancer cells. It's a phase II study which means it focuses on the drug's efficacy and side effects.

Participant Groups

Group I: Treatment (poziotinib) Experimental Treatment 1 Intervention

Patients receive poziotinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Spectrum Pharmaceuticals, Inc

Industry Sponsor

Trials

83

Recruited

8,200+

Tom Riga

Spectrum Pharmaceuticals, Inc

Chief Executive Officer since 2021

Bachelor's degree in Business Administration from the University of Rhode Island

Francois Lebel

Spectrum Pharmaceuticals, Inc

Chief Medical Officer since 2018

MD from McGill University

Findings from Research

In a phase II study involving 30 patients with advanced HER2 exon 20 mutant non-small-cell lung cancer (NSCLC), poziotinib demonstrated a confirmed objective response rate of 27%, indicating its potential effectiveness as a targeted therapy.

The treatment was associated with a median overall survival of 15 months and a median progression-free survival of 5.5 months, although it also had notable side effects, including skin rash and diarrhea, with one possible treatment-related death from pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poziotinib for Patients With HER2 Exon 20 Mutant Non-Small-Cell Lung Cancer: Results From a Phase II Trial. Elamin, YY., Robichaux, JP., Carter, BW., et al.[2023]

Poziotinib, a novel tyrosine kinase inhibitor, shows moderate efficacy in treating HER2 exon 20 mutant non-small-cell lung cancer (NSCLC), with an objective response rate of 27% and a disease control rate of 72% based on a pooled analysis of three clinical trials involving 126 patients.

The treatment has a manageable safety profile, with the most common severe side effects being skin rash (36%), diarrhea (23%), and oral mucositis (13%), indicating that while effective, monitoring for these adverse events is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poziotinib in non-small-cell lung cancer patients with HER2 exon 20 mutations: A pooled analysis of randomized clinical trials. Wang, BC., Kuang, BH., Liu, XX., et al.[2022]

The maximum tolerated dose (MTD) of poziotinib when combined with paclitaxel and trastuzumab for treating HER2-positive advanced gastric cancer was determined to be 8 mg/day, with manageable toxicity observed in the study.

In a cohort of 44 patients, the treatment combination showed promising efficacy, with a 21.9% objective response rate and median progression-free survival of 13 weeks, indicating potential benefits for patients previously treated with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer. Kim, TY., Han, HS., Lee, KW., et al.[2023]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

A Phase II Study of Poziotinib in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Lung Adenocarcinoma Who Have Acquired Resistance to EGFR-Tyrosine Kinase Inhibitors. [2019]

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

Poziotinib for Patients With HER2 Exon 20 Mutant Non-Small-Cell Lung Cancer: Results From a Phase II Trial. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Phase 1 Studies of Poziotinib, an Irreversible Pan-HER Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumors. [2022]

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

Poziotinib in non-small-cell lung cancer patients with HER2 exon 20 mutations: A pooled analysis of randomized clinical trials. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer. [2023]