Whole Genomic Landscape of Advanced EGFR-mutant NSCLC
South Korea148 participantsStarted 2019-05-23
Plain-language summary
This is a phase 2 single-arm, non-randomized multicentre and tissue acquisition study to evaluate acquired resistance mechanisms, efficacy, and safety in advanced, EGFR tyrosine kinase inhibitor-naïve NSCLC patients with EGFR-activating mutations who receive a first-line osimertinib orally at a dose of 80mg once daily.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Male or female must be \> 19 years of age
✓. Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
✓. Male subjects should be willing to use barrier contraception (see Restrictions, Section 3.8)
✓. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of EGFR TKI-sensitizing mutation (EGFR exon 19 deletion or L858R mutation), either alone or in combination with other EGFR mutations excluding EGFR exon 20 insertion mutation
✓. Mandatory provision of fresh tumor sample before osimertinib via a biopsy or surgical resection
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Patients must have a life expectancy ≥ 12 weeks.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study
✕. Previous treatment with an EGFR TKI
✕. Patients with different kinds of cancers within 5 years or with malignants simultaneously (except completely cured skin basal cell carcinoma or uterine cervical cancer)
What they're measuring
1
Proportion of acquired resistance mechanisms to osimertinib at disease progression
Timeframe: Through study completion, an average of 2 years
✕. Treatment with an investigational drug within five half-lives or 3 months. Patients receiving an radiotherapy targeting brain metastasis or spinal cord compression within 2 weeks before the beginning of study treatment, receiving an wide field radiotherapy over 30% of spinal cord reactivity or who are unrecovered from radiotherapy toxicity
✕. Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4
✕. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy
✕. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
✕. Patients with spinal cord compression, symptomatic or unstable brain metastases except for those patients who have completed definitive therapy and have had a stable neurological status for at least 2 weeks after completion of definitive therapy. Patients who may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks (14 days) prior to the start of study treatment and are clinically asymptomatic are eligible