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New treatment option for Non-Small Cell Lung Cancer Metastatic
Official title Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
ClinicalTrials.gov ID: NCT06106802
What this study is testing
What is Lazertinib?
Lazertinib is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 subsequent therapeutic option has been highlighted. From the 1st line Osimertinib treatment, the heterogenous resistance mechanism has been observed showing most commonly by MET amplification (7-15%) followed by additional on-target EGFR mutation (6-10%), BRAF, PI3KCA, KRAS, HER2 mutation (13-14%) and still 40 to 50% remain unknown for the mechanism.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a...
- Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial response, complete...
- First-line cytotoxic chemotherapy received as palliative treatment is acceptable after the failure of Lazertinib (Patients with disease progression...
- 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...
- Available tissue for MET FISH
You likely can't join if
- 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...
- 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...
See the full eligibility 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)
- 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...
- 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...
- 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...
- 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...
- Agreed to perform re-biopsy at the timepoint of disease progression
- Female people must either be of non-reproductive potential
- Subject willing and able to comply with the protocol
- Signed written informed consent
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Gangnam-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Gangnam-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.