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Association details:
| Biomarker: | EGFR exon 19 deletion |
|---|---|
| Cancer: | Lung Cancer |
| Drug: | gefitinib (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Excerpt:
IRESSA is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Source:
Title:
Selumetinib in Combination With Gefitinib in NSCLC Patients
Excerpt:
...Must have discontinued any previous anti-cancer and investigational therapy (excluding EGFR TKI) for at least 28 days or radiotherapy ≥14 days before study treatment administration, and must have recovered to Grade 1 from the adverse effects of such treatment before starting study treatment....
Source:
Title:
Clinical study of gefitinib combined with recombinant human endostatin or gefitinib in the first-line treatment of EGFR mutation positive advanced NSCLC
Excerpt:
...Patients with advanced non-small cell lung cancer (NSCLC) confirmed by histopathology or cytology, who can not be operated or have postoperative recurrence and metastasis [2009 IASLC international lung cancer staging (8th Edition) TNM stage III B-IV, see Appendix 2 of the trial protocol], according to the definition of the joint committee on cancer staging standards, they are not suitable for radical treatment; To confirm EGFR 19del or L858R mutation according to the detection method recommended by "expert consensus on detection of epidermal growth factor receptor gene mutation in Chinese patients with non-small cell lung cancer"; [Chinese Journal of Pathology, 2011,40 (10): 700-702] 2. ...
Trial ID:
More C2 evidence
Source:
Title:
Evaluation of the safety, pharmacokinetics and efficacy of domestic gefitinib tablets in the treatment of patients with advanced non-small cell lung cancer by a multicenter, randomized, positive drug gefitinib (trade name: Iressa ?) Efficacy
Excerpt:
...to provide a testable specimen (tissue or cancerous pleural effusion) before the group to carry out genotyping, test results show EGFR-positive exon 19 deletion or exon 21 (L858R) mutation; 4) major organ function within 7 days prior to treatment, meeting the following criteria: (1) blood routine examination criteria (14 days without blood transfusion): hemoglobin (HB) ≥ 90g/L; neutrophil absolute (ANC) ≥ 1.5×10^9/L; platelet (PLT) ≥80×10^9/L; (2) biochemical tests to meet the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 ULN, Liver metastases, ALT and AST ≤ 5 ULN; serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low (50%). ...
Trial ID:
Source:
Title:
Evaluation of efficacy of gefitinib drug in patients with non-small cell tumors with EGFR and TP53 gene mutation Valutazione di efficacia del farmaco gefitinib in pazienti affetti da tumore non a piccole cellule con mutazione del gene EGFR e TP53
Excerpt:
...Locally identified EGFR exon 19 deletion or exon 21 p.L858R. ...
Trial ID:
Source:
Title:
Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC (ECTOP-1001)
Excerpt:
...Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation....
Trial ID:
Source:
Title:
Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance
Excerpt:
...EGFR mutation (exon 19 deletion or exon 21 L858R) with Bim deletion or low abundance for EGFR mutation....
Trial ID:
Source:
Title:
Third-line Treatment of Gefitinib in NSCLC Patients
Excerpt:
...EGFR exon 19 deletion or exon 21 L858R substitution mutation confirmed; 5....
Trial ID:
Source:
Title:
Clinical Study of YYJD Decoction Combined With Gefitinib in Advanced Pulmonary Adenocarcinoma
Excerpt:
...- With activating EGFR mutation (either exon19del or exon21L858R) and one month of gefitinib as first-line or second-line therapy without disease progression (PD);...
Trial ID:
Source:
Title:
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
Excerpt:
...Tumors with common EGFR mutations (19del or L858R) 3....
Trial ID:
Source:
Title:
Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation
Excerpt:
...- Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)...
Trial ID:
Source:
Title:
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Excerpt:
...- Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation....
Trial ID:
Source:
Title:
Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC
Excerpt:
...Harboring activating mutation of EGFR,only including an exon 19 deletion or an exon 21 point mutation....
Trial ID:
Source:
Title:
the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)
Excerpt:
...Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed by providing a detectable specimen (tissue or cancerous pleural effusion) prior to enrollment; 5....
Trial ID:
Source:
Title:
Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone
Excerpt:
...EGFR mutation assessment:...
Trial ID:
Source:
Title:
Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
Excerpt:
...Sensitive EGFR mutations (19del, 21L858R); 5....
Trial ID:
Source:
Title:
Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance
Excerpt:
...- EGFR exon 19 deletion or exon 21 L858R....
Trial ID:
Source:
Title:
Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal Growth Factor Receptor;BM-brain Metastases)
Excerpt:
...- Sequencing EGFR mutation(primary lesion or metastases,exon 19 deletions or exon 21 L858R (EGFR mutation in exon 21, L858R point mutation) mutations;...
Trial ID:
Source:
Title:
Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Excerpt:
...- Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);...
Trial ID:
Source:
Title:
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
Excerpt:
...- History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)...
Trial ID:
Source:
Title:
A exploratory Study of Apatinib and Gefitinib First-line treatment in Patients With Advanced Non-squamous Non-Small-Cell Lung Cancer Harboring EGFR Mutations
Excerpt:
...Documented evidence of tumor harboring an activating EGFR mutation (Example 19 del and 21 L858R). ...
Trial ID:
Source:
Title:
Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation
Excerpt:
...EGFR exon 19 deletion (19del) or exon 21 mutation (L858R) has been confirmed....
Trial ID:
Source:
Title:
Clinical application of dynamic monitoring EGFR acquired resistance mutations in circulating tumor cells (CTCs) of patients with non-small cell lung cancer
Excerpt:
...EGFR mutation, exon 19 Del or exon 21 L858R, must be confirmed before enrollment. ...
Trial ID:
Source:
Title:
Multicentre, randomized, placebo-controlled, double-blind study of gefitinib plus "Fuzheng Kang'ai" decoction versus gefitinib in advanced non-small-cell lung cancer patients with EGFR mutation
Excerpt:
...Harbouring activating EGFR mutations (either exon 19 deletion or L858R in exon 21); 4. ...
Trial ID:
Less C2 evidence
Source:
Title:
ctDNA analysis in patients with cancer of unknown primary and its value in guiding targeted treatment when combined with predicted cancer types by 90-gene reverse-transcription polymerase chain reaction assay.
Published date:
05/19/2021
Excerpt:
In these 7 patients, only one patient with predicted lung cancer and EGFR 19 del received gefitinib with partial response for 5+ months.
DOI:
10.1200/JCO.2021.39.15_suppl.e18730
