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A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations | Clinical Trials | Clareo Health

SUSPENDEDPHASE3

A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

A Randomized, Phase 3 Study of Poziotinib in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring HER2 Exon 20 Mutations (PINNACLE)

NCT05378763•Spectrum Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.

Detailed Description

This is a Phase 3, active-controlled, multicenter study to compare the efficacy and safety/tolerability of poziotinib versus docetaxel in previously treated participants with locally advanced or metastatic NSCLC harboring HER2 exon 20 mutations. Participants will be randomized in a 2:1 ratio to: * Arm A: Poziotinib 8 milligrams (mg), twice daily (BID) or * Arm B: Docetaxel 75 milligrams per meter square (mg/m\^2) The Screening Period lasts up to 21 days prior to Cycle 1, Day 1 (C1D1). Participants will be treated in 21-day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must:
•1. Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements
•2. Have histologically or cytologically confirmed NSCLC
•3. Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment
•4. Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC, including platinum and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated.
•5. Have documentation of HER2 exon 20 mutation
•6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
•7. Have adequate hematologic, hepatic, and renal function at Baseline as per protocol

Exclusion Criteria

•Participant:
•1. Has had previous treatment with poziotinib for treatment of NSCLC
•2. Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations
•3. Has had previous treatment with docetaxel for locally advanced or metastatic NSCLC. If docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease must have occurred ≥6 months after the last dose to be eligible
•4. Has spinal cord compression or leptomeningeal disease
•5. Has a high risk of cardiac disease, as determined by the Investigator
•6. Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies
•7. Is unable to take drugs orally
•8. Is pregnant or breast-feeding

Locations (1)

Bond Clinic, P.A.

Winter Haven, Florida, United States

Key Dates

Start Date

May 12, 2022

Primary Completion Date

December 25, 2027

Completion Date

December 25, 2028

Last Updated

February 18, 2026

Enrollment

268

ESTIMATED participants

Conditions

NSCLC

Interventions

Poziotinib

DRUG

Docetaxel

DRUG

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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