Evidence Level:Sensitive: B - Late Trials
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
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
Evidence Level:Sensitive: B - Late Trials
Title:
Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non-small cell lung cancer: A randomized, double-blind, multi-center, phase III study (FURLONG)
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
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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). ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
Excerpt:...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including at least one of G719X, exon 19 deletion, L858R, L861Q mutation) 5....
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Excerpt:...- EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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;...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A Phase II Clinical Study Evaluating the Efficacy and Safety of Adjuvant Furmonertinib for Patients With EGFR-Mutated Stage IA Non-Small Cell Lung Cancer After Non-Radical Therapy
Excerpt:...be confirmed as having an EGFR exon 19 deletion mutation (19del) or exon 21L858R point mutation (L858R) by central laboratory testing of a histological or cytological specimen, or, in the absence of a histological or cytological specimen, receive a peripheral blood test for the presence of an EGFR 19del or an EGFR 21L858R, which may be present singly or in combination;...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase I clinical study of induction radiotherapy followed by neoadjuvant chemotherapy combined with Furmonertinib and adjuvant therapy with single-agent Furmonertinib for EGFR mutated resectable non-small cell lung cancer
Excerpt:...Patients with lung adenocarcinoma confirmed by biopsy and pathology; EGFR gene mutation (19Del and/or 21 L858R);...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
High-dose furmonertinib for the first-line treatment of treatment of EGFR mutant NSCLC with co-occurring genetic alterations : an open-label, single-arm study
Excerpt:...4.Patient with EGFR 19Del or L858R mutation in combination with co-occurring genetic alterations diagnosed histologically or cytologically, the reports must be issued or recognized by central laboratory. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
The efficacy and safety of furmonertinib 160mg as first line in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR classical mutations, a prospective, single-arm, multicenter clinical study
Excerpt:...3.Patients have been confirmed by local laboratory to have one of the following EGFR mutations: 19Del or L858R (single or compound);...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A multicenter, open label, single arm study: furmonertinib as neoadjuvant therapy for resectable stage IIIA EGFR mutant lung adenocarcinoma
Excerpt:...5.EGFR mutation positive (must include deletion of exon 19 and/or mutation of exon 21 L858R, which can exist alone or in combination); 6.Presence of at least one accurately measurable lesion, computed tomography (CT) showing a maximum diameter of >10mm at baseline (except for lymph nodes with a shorter axis > 15mm) and suitable for accurate repeat measurements; 7.ECOG performance status score 0-1; 8.Sufficient organ function to meet protocol requirements....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
A prospective, single-arm clinical study of furmonertinib combined with chemotherapy in the first-line treatment of patients with EGFR mutant locally advanced or metastatic non-small cell lung cancer
Excerpt:...6) Histological or cytological confirmation of the presence of the EGFR 19DEL or L858R mutation, either alone or in combination, from a tertiary care hospital....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Excerpt:...- Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including at least one of G719X, exon 19 deletion, L858R, L861Q mutation)...
