NSCLC Clinical Trial
— PINNACLEOfficial 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)
Verified date | February 2024 |
Source | Spectrum Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 268 |
Est. completion date | December 25, 2028 |
Est. primary completion date | December 25, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Participant must: 1. Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements 2. Have histologically or cytologically confirmed NSCLC 3. Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment 4. 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. 5. Have documentation of HER2 exon 20 mutation 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7. Have adequate hematologic, hepatic, and renal function at Baseline as per protocol Exclusion Criteria: Participant: 1. Has had previous treatment with poziotinib for treatment of NSCLC 2. Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations 3. 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 4. Has spinal cord compression or leptomeningeal disease 5. Has a high risk of cardiac disease, as determined by the Investigator 6. Has a history of, or signs of Grade =2 pneumonitis on current imaging studies 7. Is unable to take drugs orally 8. Is pregnant or breast-feeding |
Country | Name | City | State |
---|---|---|---|
United States | Bond Clinic, P.A. | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Spectrum Pharmaceuticals, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to approximately 5 years | |
Secondary | 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. | Up to approximately 5 years | |
Secondary | 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. | Up to approximately 5 years | |
Secondary | 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. | Up to approximately 5 years |
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