A single-arm, open-label, Phase 2 study evaluating the efficacy, safety and pharmacokinetics of HM61713 (BI 1482694) in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)

Hanmi Pharmaceutical Co., Ltd.0 sites150 target enrollmentDecember 21, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Hanmi Pharmaceutical Co., Ltd.
Enrollment: 150
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 21, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Hanmi Pharmaceutical Co., Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Provide written informed consent before any study\-specific procedures (including special Screening tests) are performed.
•2\. At least 20 years of age at the time of signing informed consent.
•3\. Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
•4\. Radiologically confirmed disease progression after at least one line of treatment with an EGFR\-TKI with or without at least one line of chemotherapy.
•5\. At least one documented EGFR mutation which is known to be related with susceptibility to EGFR\-TKIs (including G719X, exon 19 deletion, L858R, and L861Q).
•6\. World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
•7\. Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
•8\. At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1\.1\.
•9\. Adequate hematological and biological function as follows:
•a. Absolute neutrophil count (ANC) \= 1\.5 x 109/L; hemoglobin \= 9\.0 g/dL; platelets \= 100 x 109/L without the use of hematopoietic growth factors.

Exclusion Criteria

•1\. Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713\.
•2\. Treatment with any of the following:
•a. Anticancer therapies including chemotherapy, hormonal treatment, or immunotherapy within 14 days of the first administration of study drug.
•b. Treatment with an EGFR\-TKI (including erlotinib, gefitinib, and afatinib) within 8 days or 5\-fold half\-life, whichever is the longer, of the first administration of study drug.
•c. Previous treatment with the combination of afatinib\+cetuximab HM61713, or other drugs that target T790M\-positive mutant EGFR with sparing of wild\-type EGFR (e.g. AZD9291, CO\-1686\).
•d. Treatment with any investigational agent(s) within 28 days prior to the first administration of study drug.
•e. Radiotherapy with wide\-field or more than 30% of the bone marrow within the past 2 weeks prior to the first administration of study drug; localized palliative radiation (e.g. localized skeletal metastasis) is permitted.
•f. Any non\-study related significant surgical procedures within the past 28 days prior to the first administration of study drug, except those related to this study.
•3\. Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases except for the followings:
•a. Asymptomatic brain metastases incidentally found during screening process which do not require corticosteroids and/or local treatment in the opinion of the investigator.