CompletedPhase 2

Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

South Korea15 participantsStarted 2018-01-04

Plain-language summary

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

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.
✓. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of the EGFR exon 20 insertion mutation
✓. Disease progression while on standard chemotherapy (platinum doublet chemotherapy or single-agent chemotherapy in selected patients)
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Patients must have a life expectancy ≥ 12 weeks
✓. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test 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 patients should be willing to use barrier contraception

Exclusion criteria

✕. Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
✕. Previous treatment with osimertinib (3rd generation EGFR TKIs such as olumtinib, EGF816 etc)
✕. Treatment with an investigational drug within five half-lives of the compound
✕. Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4.
✕. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (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 symptomatic CNS metastases who are neurologically unstable; however, those with asymptomatic CNS metastases who do not require steroids for at least 4 weeks prior to start of osimertinib are eligible.
✕. Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD

What they're measuring

Objective Response Rate

Timeframe: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)

Trial details

NCT IDNCT03414814

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-03

Results submitted2024-08-13

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