A Multicenter Phase II study of Trastuzumab emtansine for non-small cell lung cancer positive for HER2 exon 20 insertion mutation.

Phase 2

• Conditions: Advanced non-small cell lung cancer positive for HER2 exon 20 insertion mutation

• Registration Number: JPRN-UMIN000035622
• Lead Sponsor: Kyushu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study Completion: 2021-03-31
• Results First Posted: 2021-12-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients with an infection requiring systemic treatment 2.Patients with treatment history of HER2 inhibitors 3.History of hypersensitivity of grade 3 or more to additive substance (sodium succinate, sucrose, polysorbate 20) of that of severe hypersensitivity to other drugs 4.Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study. 5.With driver mutation other than HER2 mutation (EGFR activating mutation, ALK fusion gene, ROS1 fusion gene, BRAF V600E, RET fusion gene, MET exon 14 skip mutation, NTRK fusion gene) 6.Patients with symptomatic brain metastases 7.Patients with carcinomatous meningitis 8.Patients with active double cancer 9.Patients with poorly controlled hypertension or diabetes mellitus 10.Patients with clinically meaningful heart diseases including 1)New York Heart Association(NYHA)class II or more or heart disorder with Grade 3 or more assessed by CTCAE v5.0 2)Patients with congestive heart failure or medication-needed ventricular arrythmia within 6 months 11.Patients with clinically meaningful coronary artery disease (unstable angina, myocardial infarct) within 6 months 12. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody 13. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT 14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate: RR

Secondary Outcome Measures

Name	Time	Method
Progression-free survival: PFS Overall Survival: OS Duration of Response: DoR Percentage of patients with at least 1 adverse event