SuspendedNCT05378763PINNACLEUpdated Sep 1, 2026

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

A Phase 3 interventional study of Poziotinib and Docetaxel in NSCLC, sponsored by Spectrum Pharmaceuticals, Inc. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Spectrum Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment

Why this study was suspended

The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.

Phase: Phase 3
Study type: Interventional
Enrollment: 268
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

NSCLC

Keywords

Epidermal growth factor receptor (EGFR)
HER2
Exon 20 mutation

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 268 participants (estimated)

Study arms

Experimental
Poziotinib 8 mg
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
Active comparator
Docetaxel 75 mg/m^2
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

DrugPoziotinib
Poziotinib tablets
Also known as: HM781-36
DrugDocetaxel
Docetaxel IV infusion

What researchers measure

Primary outcomes

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.
Time frame: Up to approximately 5 years

Secondary outcomes

Overall survival (OS)
OS is defined as the time (in months) from the start of study treatment to the date of death due to any cause.
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve at least one complete response (CR) or partial response (PR) by the central radiographic evaluation as per the RECIST v.1.1 criteria, before disease progression. Per RECIST v.1.1 for solid tumors, CR is defined as disappearance of all tumor lesions (TLs) and disappearance or reduction of all pathological lymph nodes \<10mm (short axis). PR is ≥30% decrease in sum of diameters (SOD) from Baseline.
Time frame: Up to approximately 5 years
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve at least one CR, PR, stable disease (SD), or non-CR/non-progressive disease (PD), by the central radiographic evaluation per the RECIST v.1.1 criteria, before disease progression. Per RECIST v.1.1 for solid tumors, CR is defined as disappearance of all tumor lesions (TLs) and disappearance or reduction of all pathological lymph nodes \<10mm (short axis). PR is ≥30% decrease in sum of diameters (SOD) from Baseline, and non PD is ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm). SD is SOD change neither sufficient for PR nor sufficient for PD.
Time frame: Up to approximately 5 years

Study locations

1 site

Bond Clinic, P.A.
Winter Haven, Florida 33880, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05378763
Lead sponsor: Spectrum Pharmaceuticals, Inc
Responsible party: Sponsor
First posted: May 18, 2022
Start date: May 12, 2022
Primary completion: Dec 25, 2027 (estimated)
Completion: Dec 25, 2028 (estimated)
Last update: Sep 1, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Spectrum Pharmaceuticals, Inc

Start the discussion