Status:
UNKNOWN
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
Lead Sponsor:
Yonsei University
Conditions:
NSCLC
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate the antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as th...
Eligibility Criteria
Inclusion
- 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).
- Confirmed uncommon EGFR mutations (e.g. G719X, S768I, L861Q, G719X + S768I, G719X + L861Q, L861Q + S768I, L747S, S720A, E709A, exon 18 deletion) without common EGFR mutations including exon 19 deletion, L858R, exon 20 insertion, or T790M. (The result from both cell-free DNA or tissue-based DNA is allowed.)
- Age of 20 or more.
- Performance status of Eastern Cooperative Oncology Group 0 to 2.
- At least one measurable lesion by RECIST 1.1(The part of radiation treatment in the palliative setting is excluded.)
- Untreated asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery, and stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
- At least 2 weeks later after whole brain radiotherapy or palliative thoracic radiotherapy
- Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; hemoglobin \> 9.0g/dL; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 2.5 ULN if no demonstrable liver metastases or \< 5 UNL in the presence of liver metastases; CCr ≥ 50mL/min
- Written informed consent form
Exclusion
- Previously treatment with any kind of EGFR TKI
- Uncontrolled central nervous system metastases
- Leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
- Cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14days of first dose of study treatment, or any investigational drugs within 5 x half-lives of the compound
- Major surgery undertaken less than 4 weeks before the study
- Localized palliative radiotherapy unless completed more than 2 weeks before the study
- Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method, contraception until 3 months after discontinuation of drug for female, hormonal methods should be used in combination with barrier methods)
- Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer, early gastric cancer or otherwise confirmed as curative malignancy disease by principal investigator
- Any of the following cardiac criteria:
- Prolonged QT interval in ECG (QTc \> 450 msec)
- Any clinically important abnormalities in rhythm, conduction conduction or morphology of resting ECG eg complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec
- Any other factors that increase risk of QT or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 yers og age in first degree relatives or concomitant medications known to prolong QT interval
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05277701
Start Date
April 1 2022
End Date
December 1 2024
Last Update
March 14 2022
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea