CompletedPhase 2

Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)

South Korea73 participantsStarted 2020-11-17

Plain-language summary

This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✓. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
✓. Male and female patients must be at least 18 years of age.
✓. Patients must have documented (only allowed for EGFRm+ \[exon 19 deletions or L858R\] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below:
✓. All patients will be required to have NSCLC associated with at least 1 site of LM as identified by the Investigator that can be assessed by MRI scan and that is suitable for repeat assessments. Measurable INC or EXC disease by RECIST 1.1 is not required. Concomitant brain metastases and brain metastases previously treated with radiation therapy are allowed. In addition, asymptomatic untreated BM is also allowed.
✓. EGFR TKI pre-treated patients must have had at least 1 prior EGFR TKI (eg, gefitinib, erlotinib, icotinib, dacomitinib or afatinib) and may have had other lines of therapy
✓. If the patients is T790M negative, EXC must be stable following previous EGFR TKI treatment. EXC progression is allowed if patients are T790M positive patients
✓. ECOG/WHO performance status 0 to 2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.

Exclusion criteria

✕. EGFR TKI pre-treated patients whose T790M mutation status cannot be determined.
✕. EGFR TKI pre-treated patients with progressing EXC disease who are T790M mutation-negative. Progressing EXC disease is defined as RECIST 1.1 PD no more than 3 months prior to enrollment, per Investigator assessment.
✕. Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
✕. Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.
✕. Any of the following cardiac criteria:
✕. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
✕. Known INC hemorrhage that is unrelated to tumor.
✕. Patients with the clinical manifestation of nervous system failure including severe encephalopathy or with severe nervous system injury related with treatment, such as chemical meningitis.

What they're measuring

Overall survival

Timeframe: Up to 30 months

Trial details

NCT IDNCT04563871

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-25

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