A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations (PINNACLE)
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- STATUS
- Recruiting
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- End date
- Dec 25, 2028
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- participants needed
- 268
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- sponsor
- Spectrum Pharmaceuticals, Inc
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 Identifier | NCT05378763 |
| Sponsor | Spectrum Pharmaceuticals, Inc |
| Last Modified on | 27 June 2022 |
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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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