Clinical trial NCT04510415: Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI
Official title: A Single-arm, Open-label, Phase 1b Study Evaluating the Efficacy and Safety of Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Duration of overall tumor response (DR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Time to progression (TTP)
timeFrame: 24 months
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ. of Korea Bucheon St.Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ. of Korea St.Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ. of Korea Uijeongbu St.Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Incheon St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St.Mary's Hospital
Study officials:
affiliation: Hanmi Pharmaceuticals
name: Hanmi Pharmaceuticals
role: STUDY_DIRECTOR
References: