Status:
TERMINATED
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve N...
Detailed Description
The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Participant must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible partici...
Eligibility Criteria
Inclusion
- Key
- Participant must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
- Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
- Prior treatment status:
- Cohorts 1 and 2: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
- Cohorts 3 and 4: Participant is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
- Cohort 5: Participants who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
- Cohort 6: Participant with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
- Cohort 7: Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
- Specific mutations:
- Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
- Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
- Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
- Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression)
- Cohort 7: Documented EGFR or HER2 activating mutations
- Participant has adequate organ function at Baseline
- Key
Exclusion
- Participant has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible (Cohorts 1 and 2).
- Participant is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed
- Participant has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully-treated and stable, early-stage prostate cancer, or carcinoma in situ of the cervix or breast without need of treatment
- Participant is pregnant or breast-feeding
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2023
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT03318939
Start Date
October 13 2017
End Date
April 3 2023
Last Update
April 3 2024
Active Locations (63)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Oncology Physician's Network Inc./OPN Healthcare
Arcadia, California, United States, 91007
3
City of Hope
Duarte, California, United States, 91010
4
UCSD -Moores Cancer Center
La Jolla, California, United States, 92093