Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

Hanmi Pharmaceutical

Status and phase

Terminated

Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Olmutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04510415

HM-EMSI-103

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Full description

This is a single-arm, open-label, Phase 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI.

Enrollment

2 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
At least 20 years of age at the time of signing informed consent.
Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy.
Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy.
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).
World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months.
Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen.
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.
Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug.
Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms.
Recovery to ≤ Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy ≤ Grade 2 and alopecia.

Exclusion criteria

Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
Previous treatment with anticancer therapies, 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.
Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
History of any other malignancy
Clinically significant uncontrolled condition(s)
Active or chronic pancreatitis
Anyone with cardiac abnormalities or history
Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of radiation pneumonitis.
Pregnant or breast feeding.
In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713.