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

Phase 2

Completed

• Conditions: Adenocarcinoma Lung Stage IV; HER2 Gene Mutation
• Interventions: Drug: Poziotinib

• Registration Number: NCT02979821
• Lead Sponsor: Korean Association for the Study of Targeted Therapy

Brief Summary

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

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Poziotinib	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to progression, TTP	through study completion (3 years)	from first IP administration to date of first documented progression

Trial Locations

Locations (1)

Korean Association for the Study of Targeted Therapy; 🇰🇷 Seoul, Korea, Republic of