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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Leclaza (lazertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Yuhan's Leclaza indication expanded as 1st-line NSCLC treatment
Published date:
06/30/2023
Excerpt:
The Ministry of Food and Drug Safety (MFDS) has approved an expanded indication for Yuhan Corp.'s Leclaza (ingredient: lazertinib), an epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treatment, to be used as first-line treatment.
Source:
Title:
1324MO - CNS outcomes of lazertinib vs gefitinib in EGFR-mutated advanced NSCLC: A LASER301 subset analysis
Published date:
10/16/2023
Excerpt:
In the phase 3 LASER301 study (NCT04248829), treatment (tx)-naïve pts with EGFR-mutated advanced or metastatic NSCLC were randomized 1:1 to laz (240 mg/day) or gef (250 mg/day)...iORR was higher for the laz (n=17, 94%) vs gef (n=11, 73%) group...In pts with BL CNS mets, laz significantly improved iPFS vs gef with more durable responses. Laz has the potential to improve CNS outcomes in NSCLC.
Trial ID:
Source:
Title:
Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC
Excerpt:
...- Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations....
Source:
Title:
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. Estudio en fase II abierto y de cohortes paralelas de amivantamab subcutáneo con diversas pautas posológicas en pacientes con tumores sólidos avanzados o metastásicos, incluido el cáncer de pulmón no microcítico con mutaciones en el gen EGFR.
Excerpt:
...Participant must have histologically or cytologically confirmed, locally advanced or metastatic, NSCLC, characterized at the time of locally advanced or metastatic disease diagnosis.Additional Cohort specific disease requirements include:Cohorts 1 and 3: EGFR Exon19del or L858R mutationCohort 2: EGFR Exon 20ins mutationEGFR Exon19del or Exon 21 L858R mutation (Cohort 1 and 3) or EGFR Exon 20 insertion mutation (Cohort 2) must have been identified as determined by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US). ...
Trial ID:
More C2 evidence
Source:
Title:
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Excerpt:
...- In Part D: Participants outside Korea with histologically or cytologically (that is, using pleural effusion, ascites) confirmed Non-Small Cell Lung Cancer (NSCLC) with previously diagnosed epidermal growth factor receptor single activating mutation positive (EGFRm+), and who have had progressive disease on prior epidermal growth factor receptor- Tyrosine kinase inhibitor (EGFR-TKI) therapy...
Source:
Title:
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
Excerpt:
...Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory....
Trial ID:
Source:
Title:
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Excerpt:
...- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations...
Source:
Title:
Lazertinib 160mg in EGFR T790M NSCLC
Excerpt:
...- EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI...
Source:
Title:
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Excerpt:
...- Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)...
Trial ID:
Source:
Title:
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Excerpt:
...patients with NSCLC with local progressive or metastatic EGFR T790M mutation who have previously been treated with Generation 1 or Generation 2 EGFR TKI...
Source:
Title:
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Excerpt:
...EGFR gene mutations in the test on bronchoalveolar lavage fluid:...
Trial ID:
Source:
Title:
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
Excerpt:
...Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation....
Trial ID:
Less C2 evidence
Source:
Title:
YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer
Excerpt:
Antitumor activity of YH25448 was investigated in vitro using mutant EGFR-expressing Ba/F3 cells and various lung cancer cell line....Compared with osimertinib, YH25448 showed a higher selectivity and potency in kinase assay and mutant EGFR-expressing Ba/F3 cells.
DOI:
10.1158/1078-0432.CCR-18-2906
