Poziotinib for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Spectrum Pharmaceuticals, Inc

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

Eligibility Criteria

This trial is for NSCLC patients with specific mutations (EGFR or HER2 exon 20). It includes those who've had prior treatments and treatment-naïve individuals. Participants must have advanced or metastatic cancer, not curable by surgery or radiation, and good organ function. Pregnant women, breastfeeding mothers, and those treated with similar drugs are excluded.

Inclusion Criteria

You have received at least one treatment for advanced lung cancer.

You have a specific mutation called EGFR exon 20 insertion.

If you are in Cohorts 3 or 4, you have not received treatment before for advanced lung cancer and you can take poziotinib as your first treatment. Any previous treatments must have ended at least 15 days before the study starts.

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Exclusion Criteria

You have taken a specific type of medication for your condition before joining the study. The currently approved medications are allowed, but others are not.

You have had any other types of cancer in the past 3 years, except for certain skin, prostate, cervix, or breast conditions that have been treated and are stable.

You are currently receiving certain cancer treatments, or have recently received them, and may not be eligible if you have had other treatments recently.

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Treatment Details

Interventions

Poziotinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe study tests Poziotinib's effectiveness and safety in various patient groups based on their treatment history and genetic mutation type. This Phase 2 trial involves multiple centers where participants receive the drug to see how well it works against lung cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PoziotinibExperimental Treatment1 Intervention

* Cohort 1: Previously treated participants with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment) * Cohort 2: Previously treated participants with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment) * Cohort 3: Treatment naïve participants with EGFR exon 20 insertion-mutant positive NSCLC (fully enrolled) * Cohort 4: Treatment naïve participants with HER2 exon 20 insertion mutant positive NSCLC * Cohort 5: Participants who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed * Cohort 6: Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib * Cohort 7: Participants with EGFR or HER2 activating mutations