Status:
NOT_YET_RECRUITING
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Lead Sponsor:
Samsung Medical Center
Conditions:
Non-Small Cell Lung Cancer Metastatic
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
As the 3rd generation, EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients, the necessity for evaluating resistant mechanism to determine the matched subs...
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 EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial response, complete response or stable disease last more than 6 months after initiation of Lazertinib) - patient can maintain the treatment with prior EGFR treatment as beyond progression until the patient start the treatment per this protocol
- First-line cytotoxic chemotherapy received as palliative treatment is acceptable after the failure of Lazertinib (Patients with disease progression after adjuvant or neoadjuvant chemotherapy within 6 months are eligible to participate)
- Patient with MET amplification FISH GCN ≥5 and/or MET/CEP7 ≥ 2 (If additional resistance mechanism to lazertinib, such as C797S, is observed with MET amplification, the recruitment needs to be discussed in advance with the principal investigator)
- Available tissue for MET FISH
- 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
- Absolute neutrophil count (ANC) ≥1500cells/mm3
- Platelet count ≥100,000cells/mm3
- Total bilirubin ≤1.5 x upper limit of normal(ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (or ≤5.0 x ULN, if liver metastasis is present)
- Creatinine level ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45mL/min (Calculated with Cockcroft- Gault equation)
- Available to provide the adequate tissue and blood for the genomic tests
- \- At least 20 unstained slide and 20 cc of blood at baseline and disease progression (If not, participant must be confirmed by the principal investigator
- Agreed to perform re-biopsy at the timepoint of disease progression
- Female subjects must either be of non-reproductive potential
- Subject willing and able to comply with the protocol
- Signed written informed consent
Exclusion
- Previously treatment with any kind of EGFR TKI other than lazertinib
- All concurrent and/or other active malignant tumors requiring systemic therapy within 2 years prior to the initial administration of the investigational drug (However, the patient may participate if previous malignant tumor has been cured, and no further treatment is required)
- Uncontrolled central nervous system metastases
- Spinal cord compression, leptomeningeal carcinomatosis
- Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
- Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
- Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
- Prior history of interstitial lung disease (ILD) or ILD like symptoms
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
- No measurable lesion
- Unable to swallow the product due to refractory nausea, vomiting or chronic gastrointestinal disease
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06106802
Start Date
February 2 2024
End Date
September 30 2029
Last Update
October 30 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351