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

NCT05378763 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: SPI-POZ-301
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Keywords

Epidermal growth factor receptor (EGFR); HER2; Exon 20 mutation

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time (in months) from the start of the study treatment to the date of first documented disease progression by central radiographic evaluation per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) or death due to any cause, whichever occurs first.

  Up to approximately 5 years

Secondary Outcomes (3)

• Overall survival (OS)

  Up to approximately 5 years

• Objective Response Rate (ORR)

  Up to approximately 5 years

• Disease Control Rate (DCR)

  Up to approximately 5 years

Study Arms (2)

Poziotinib 8 mg

EXPERIMENTAL

Participants will receive poziotinib 8 mg, orally, BID, 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 for participant withdrawal from the study.

Drug: Poziotinib

Docetaxel 75 mg/m^2

ACTIVE COMPARATOR

Participants will receive docetaxel 75 mg/m\^2, intravenously (IV) on Day 1 of each 21-day treatment cycle or until disease progression, death, intolerable AEs, initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons for participant withdrawal from the study.

Drug: Docetaxel

Interventions

Poziotinib DRUG

Poziotinib tablets

Also known as: HM781-36

Poziotinib 8 mg

Docetaxel DRUG

Docetaxel IV infusion

Docetaxel 75 mg/m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must:
• Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements
• Have histologically or cytologically confirmed NSCLC
• Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment
• 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.
• Have documentation of HER2 exon 20 mutation
• Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Have adequate hematologic, hepatic, and renal function at Baseline as per protocol

You may not qualify if:

• Participant:
• Has had previous treatment with poziotinib for treatment of NSCLC
• Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations
• 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
• Has spinal cord compression or leptomeningeal disease
• Has a high risk of cardiac disease, as determined by the Investigator
• Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies
• Is unable to take drugs orally
• Is pregnant or breast-feeding

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

Bond Clinic, P.A.

Winter Haven, Florida, 33880, United States

Location

MeSH Terms

Interventions

HM781-36B; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 18, 2022
• Study Start: May 12, 2022
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)