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Association details:
| Biomarker: | EGFR exon 19 deletion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ivesa (firmonertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study
Published date:
06/02/2022
Excerpt:
The FURLONG study is a multicentre, double-blind, randomised, phase 3 study done in 55 hospitals across mainland China. We enrolled patients who were aged 18 years or older and had histologically confirmed, locally advanced or metastatic, stage IIIB, IIIC, or IV unresectable NSCLC with EGFR exon 19 deletions or exon 21 Leu858Arg mutation on tissue biopsy confirmed by a central laboratory....Furmonertinib showed superior efficacy compared with gefitinib as first-line therapy in Chinese patients with EGFR mutation-positive NSCLC, along with an acceptable safety profile without new signals.
DOI:
https://doi.org/10.1016/S2213-2600(22)00168-0
Trial ID:
Source:
Title:
Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non-small cell lung cancer: A randomized, double-blind, multi-center, phase III study (FURLONG)
Published date:
03/23/2022
Excerpt:
Stage IIIB/IIIC/IV NSCLC patients with EGFR Ex19Del or L858R mutation positive were enrolled to receive either furmonertinib 80 mg/d or gefitinib 250 mg/d as first-line therapy….The median PFS with furmonertinib was significantly longer than with gefitinib (20.8 versus 11.1 months; HR 0.44 [95%CI 0.34-0.58]; p<0.0001)....Furmonertinib significantly prolonged PFS and showed less grade >/= 3 TRAEs compared with gefitinib as first-line treatment in advanced EGFR mutated NSCLC patients.
DOI:
https://doi.org/10.1016/j.annonc.2022.02.010
Trial ID:
Source:
Title:
To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
Excerpt:
...- Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
Source:
Title:
Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）
Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)....
More C2 evidence
Source:
Title:
AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Excerpt:
...- Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g....
Source:
Title:
High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
Excerpt:
...Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation....
Trial ID:
Source:
Title:
Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC
Excerpt:
...- 7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)...
Trial ID:
Source:
Title:
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)
Excerpt:
...The tumour harbours one of the most common EGFR mutations (19del or L858R); 4....
Trial ID:
Source:
Title:
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
Excerpt:
...- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)...
Trial ID:
Source:
Title:
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
Excerpt:
...The tumour harbours one of the most common EGFR mutations (19del or L858R) ; 7....
Trial ID:
Source:
Title:
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Excerpt:
...- EGFR mutation positive (19Del or L858R, with or without T790M)...
Trial ID:
Source:
Title:
Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC
Excerpt:
...- an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;...
Source:
Title:
The efficacy and safety of Furmonertinib in advanced EGFR mutation-positive NSCLC patients with brain metastases based on real-time dynamic monitoring of peripheral blood and CSF
Excerpt:
......
Trial ID:
Source:
Title:
A Clinical Study of Furmonertinib Combined with Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIA EGFRm NSCLC
Excerpt:
...EGFR-sensitive mutations (either exon 19 deletion or L858R in exon21); 5. ...
Trial ID:
Source:
Title:
A multicenter, single-arm clinical study to evaluate the efficacy and safety of Furmonertinib treatment in patients with resectable multiple primary NSCLC after one-side R0 resection
Excerpt:
...Patient diagnosed with Multiple Primary Lung Cancer (MPLC) (based on M-M/ACCP clinical criteria), identified on preoperative chest CT scan (1mm layer thickness) evaluation; patient with resectable multiple lung cancer in both lungs, with R0 resection of the primary lesion on one side (lesion >=1cm, postoperative pathology stage Ib or higher), and confirmed of EGFR gene sensitive mutations (19Del, and or 21L858R mutations). ...
Trial ID:
Source:
Title:
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
Excerpt:
...Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g....
Less C2 evidence
Source:
Title:
Efficacy and Safety of Furmonertinib 160 mg as First-line Therapy for EGFR-mutated Advanced NSCLC Patients with CNS Metastases
Published date:
08/08/2023
Excerpt:
The CNS ORR in patients with Ex19Del was higher than that in patients with L858R (100% vs. 75%)….Furmonertinib 160mg orally once daily has shown encouraging efficacy as first-line therapy in EGFR-mutated advanced NSCLC patients with CNS metastases.
