Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients (NCT05463224) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
South Korea150 participantsStarted 2023-01-04
Plain-language summary
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
* Stage IIIC or IV by AJCC 8th edition
* Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
* Age of 19 or more.
* Performance status of Eastern Cooperative Oncology Group 0 to 2.
* Expected minimum life expectancy of 12 weeks
* Adequate organ function.
* Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.
* Agreed to perform re-biopsy at the timepoint of disease progression.
* At least two weeks after the chemotherapy
* Female subjects must either be of non-reproductive potential
* Subject willing and able to comply with the protocol
* Signed written informed consent
Exclusion Criteria:
* Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
* Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
* Uncon…
What they're measuring
1
progression-free survival
Timeframe: through study completion, an average of 18.0 month