Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation

In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

Study Overview

• Status: Completed
• Conditions: HER2 Gene Mutation; Adenocarcinoma Lung Stage IV
• Intervention / Treatment: Drug: Poziotinib

Detailed Description

This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date.

The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korean Association for the Study of Targeted Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. lung adenocarcinoma, stage IV

2. Patients with HER2 mutation by sequencing

   - Confirmed triple-negative patients with remnant tumor DNA

3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
4. ECOG performance status 0~2
5. Patient with at least one measurable lesions according to RECIST

6. Patients who have proper organ functions as follows

   • Neutrophil count: > 1,500/uL
   • Platelet count: > 100,000/uL
   • Hb: > 9.0g/dL
   • AST/ALT : < 2.0 x upper normal limit
   • Bilirubin: < 1.25 x upper normal limit
   • Serum creatinine : < upper normal limit

Exclusion Criteria:

1. Expected lie expectancy < 3 months
2. CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
3. Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
4. Patients who have histories of previous exposure to EGFR-TKI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Poziotinib; The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria.	Drug: Poziotinib; A cycle of study treatment is defined as 28 days.; Other Names: NOV120101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate; ORR including rage of CR&PR	It will be assessed on based of RECIST 1.1.	through study completion (3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression, TTP	from first IP administration to date of first documented progression	through study completion (3 years)

Collaborators and Investigators

• Sponsor: Korean Association for the Study of Targeted Therapy
• Collaborators: Chonnam National University Hospital; Kyungpook National University Hospital; Konkuk University Medical Center; Chungnam National University Hospital; Kosin University Gospel Hospital
• Investigators: Principal Investigator: Kye-Young, Lee, MD, PhD, Kunkok University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (ESTIMATE): December 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pan-HER inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: PZT1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED