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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2028
  • participants needed
    268
  • sponsor
    Spectrum Pharmaceuticals, Inc
Updated on 27 June 2022
growth factor
epidermal growth factor receptor
HER2
EGFR
docetaxel
erbb2
epidermal growth factor
kidney function test
lung carcinoma

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.

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.

Details
Condition NSCLC
Treatment docetaxel, Poziotinib
Clinical Study IdentifierNCT05378763
SponsorSpectrum Pharmaceuticals, Inc
Last Modified on27 June 2022

Eligibility

Yes No Not Sure

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

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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