NSCLCPhase 3PINNACLENCT05378763
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
A Phase 3 study testing Poziotinib and Docetaxel in people with NSCLC, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Poziotinib and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 25 Dec 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoziotinibDrug
Also called HM781-36
Poziotinib tablets
DocetaxelDrug
Docetaxel IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start12 May 2022
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2028 (estimated)
Why it stopped: The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378763
- Sponsor's protocol ID
- SPI-POZ-301
- Acronym
- PINNACLE
- Status last verified
- Oct 2026
- First submitted
- 9 May 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05378763
- Acronym / sponsor ID
- PINNACLE / SPI-POZ-301
- Conditions
- NSCLC
- Keywords
- Epidermal growth factor receptor (EGFR), HER2, Exon 20 mutation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poziotinib 8 mg | Experimental | Drug: PoziotinibParticipants 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. |
| Docetaxel 75 mg/m^2 | Active comparator | Drug: DocetaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PoziotinibAlso: HM781-36Poziotinib tablets | Drug | Poziotinib 8 mg |
| DocetaxelDocetaxel IV infusion | Drug | Docetaxel 75 mg/m^2 |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
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.
3 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 5 years
Disease Control Rate (DCR)
Time frame: Up to approximately 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Poziotinib and Docetaxel in people with NSCLC, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.