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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Conmana (icotinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO–ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS
Published date:
12/28/2018
Excerpt:
Patients with druggable oncogenic drivers may derive benefit from a CNS-penetrant next-generation TKI as per those with brain metastases [III, B], as described previously for icotinib under ‘recommendation 18’ above [248].
DOI:
10.1093/annonc/mdy554
Source:
Title:
Icotinib versus chemotherapy as adjuvant treatment for stage II-IIIA EGFR-mutant non-small-cell lung cancer (EVIDENCE): a randomised, open-label, phase 3 trial
Published date:
07/21/2021
Excerpt:
...results suggest that compared with chemotherapy, icotinib significantly improves disease-free survival and has a better tolerability profile in patients with EGFR-mutant stage II-IIIA NSCLC after complete tumour resection.
DOI:
10.1016/S2213-2600(21)00134-X
Trial ID:
Source:
Title:
Clinical study of Combined action of Icotinib and brain radiotherapy on EGFR-mutated non-small-cell lung cancer patients with brain metastasis
Excerpt:
...1) patient confirmed NSCLS; 2) MRI indicated that the measurable brain metastasis lesion; 3) patient with EGFR mutations; 4) aged 18 ~ 75 years old;ECOG PS 0 ~ 2 points;Life expectancy > 3 months; 5) all subjects or their guardians must sign the subject informed consent before entering the test....
Trial ID:
Source:
Title:
Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer
Excerpt:
...Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology....
Trial ID:
More C2 evidence
Source:
Title:
Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer
Excerpt:
...- Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method...
Trial ID:
Source:
Title:
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Excerpt:
...- Patients must harbor sensitive EGFR gene mutation (19/21)...
Trial ID:
Source:
Title:
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
Excerpt:
...Sensitive EGFR gene mutation(19/21) 5....
Trial ID:
Source:
Title:
Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer
Excerpt:
...- Patients with EGFR mutation or the lesions that remains stable for more than 3 months after local treatment(WBRT and/or SRS) combined with Icotinib treatment....
Trial ID:
Source:
Title:
Icotinib concurrent thoracic radiotherapy treat for advanced non-small-cell lung cancer (NSCLC) with an activating EGFR gene mutation
Excerpt:
...Patients with stage IV non-small cell lung cancer harboring activating EGFR mutation which confirmed by histopathological or cytological examination; have at least one measurable lesion; with lesions larger than 20 mm detected by CT or MRI, or larger than 10 mm detected by PET-CT; could survival more than 3 months....
Trial ID:
Source:
Title:
A Single-arm Study to Evaluate the Efficacy of Intercalated Combination of Chemotherapy and Icotinib as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
Excerpt:
...EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. ...
Trial ID:
Source:
Title:
Randomized phase III trial of icotinib combined with thoracic radiotherapy vs. icotinib alone in treatment of advanced NSCLC patients with EGFR mutation
Excerpt:
...EGFR sensitive mutations (EGFR 19 DEL or L858R); 5. ...
Trial ID:
Source:
Title:
A Randomized Controlled Clinical Study to Explore the Clinical Value of MRD Monitoring for Adjuvant Targeted Therapy
Excerpt:
...3.Preoperative detection of EGFR sensitizing mutations (exon 19 deletion or L858R mutation in exon 21) in ctDNA. ...
Trial ID:
Source:
Title:
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
Excerpt:
...- Positive EGFR 21 exon mutation or 19 exon deletion...
Trial ID:
Source:
Title:
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Excerpt:
...- are EGFR mutation-positive or...
Trial ID:
Source:
Title:
Efficacy Study of Chinese Medicine Plus EGFR-TKI Versus EGFR-TKI in Advanced Pulmonary Adenocarcinoma
Excerpt:
...Patient with mutated EGFR will subject to first line target thearapy；patients received at least one cycle platinum-containing chemotherapy regimens with disease progression/recurrence， or intolerant/refuse to proceed with chemotherapy will explore second line target therapy; 3....
Trial ID:
Source:
Title:
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Excerpt:
...- Positive EGFR Mutation....
Trial ID:
Source:
Title:
Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
Excerpt:
...- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R)....
Trial ID:
Source:
Title:
Intercalated combination of chemotherapy and icotinib followed by icotinib maintenance compared with chemotherapy followed by icotinib maintenance in EGFR mutant patients with advanced Non-Small-Cell
Excerpt:
...The subjects must have received two cycles of gemcitabine (1000 mg/m2 on days 1 and 8, intravenously) plus platinum (cisplatin 75 mg/m2 on day 1, intravenously) as first line treatment, efficacy evaluated as DCR (CR+PR+SD); 2.Having obtained EGFR gene test, activating mutations in the EGFR gene; 3.Aged 18 to 75 years; 4. ...
Trial ID:
Source:
Title:
Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation
Excerpt:
...- Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation....
Trial ID:
Source:
Title:
A randomized, controlled, double-blind study of Fuzheng Jiedu granules in combination with icotinib in the first-line treatment of EGFR-sensitive mutated advanced lung adenocarcinoma
Excerpt:
...(1) Those who meet the diagnostic criteria for primary bronchopulmonary carcinoma, histologically or cytologically confirmed as adenocarcinoma, with EGFR 21 exon L858R and EGFR 19 exon deletion mutations identified by Arm method or second generation sequencing. ...
Trial ID:
Source:
Title:
A randomized, double-blind, parallel controlled trial for Icotinib double-dose first-line therapy for EGFR 19 exon mutations in advanced non-small cell lung cancer
Excerpt:
...EGFR gene detection 19 exon mutation; 3. ...
Trial ID:
Source:
Title:
Phase II clinical study of autologous RAK cells combined with icotinib in the treatment of EGFR-mutated advanced non-small cell lung cancer
Excerpt:
...EGFR sensitive mutation (exon 19 deletion mutation or exon 21 L858R) detected by histology or peripheral blood; 5. ...
Trial ID:
Source:
Title:
A randomized, double-blind, parallel controlled trial for Icotinib double-dose first-line therapy for EGFR 21 exon mutations in advanced non-small cell lung cancer
Excerpt:
...(1) Patients with non-small cell lung adenocarcinoma (or adenocarcinoma with initial stage IIIB/IV) that are not suitable for radical surgery or radiotherapy confirmed by pathological histology may be selected if they have been treated with adjuvant chemotherapy for more than 6 months; (2) EGFR gene detection 21 exon L858R mutation; (3) Aged 18-75 years old; (4) ECOG 0-3 points; (5) Asymptomatic brain metastasis; (6) There are imaging evaluable lesions. ...
Trial ID:
Source:
Title:
Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Excerpt:
...- Patients with uncommon epidermal growth factor receptor (EGFR) mutation...
Trial ID:
Source:
Title:
First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation
Excerpt:
...- Positive EGFR mutation confirmed by ARMS...
Trial ID:
Source:
Title:
The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation
Excerpt:
...Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation....
Trial ID:
Source:
Title:
Conmana Combined With Thalidomide to Treat NSCLC
Excerpt:
...5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations....
Trial ID:
Source:
Title:
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
Excerpt:
...- EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);...
Trial ID:
Source:
Title:
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
Excerpt:
...Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation....
Trial ID:
Source:
Title:
Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer
Excerpt:
...- Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA...
Trial ID:
Source:
Title:
Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
Excerpt:
...- Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation....
Trial ID:
Source:
Title:
A patient with advanced non-small cell lung cancer with positive epidermal growth factor receptor (EGFR) gene sensitive mutations and brain metastases was used as a test subject to evaluate the tolerance and efficacy of ametinib combined with icotinib: single arm study
Excerpt:
...(1) Sign the informed consent form voluntarily; (2) The age at the time of signing the informed consent form greater than 18 years old; (3) Patients with stage IV non-small cell lung cancer diagnosed by histopathology or cytology; (4) Patients with asymptomatic brain metastases or symptomatic brain metastases are stable after treatment; (5) The diagnosis of brain metastasis is diagnosed by imaging examinations such as computerized tomography (CT) or nuclear magnetic resonance (MRI); (6) The detection of tumor tissue samples revealed sensitive EGFR mutations and no tyrosine kinase inhibitors targeting EGFR have been used; (7) The ECOG physical status scoring standard within 2 weeks before the first use of the study drug 0-1; (8) The expected life span greater than 3 months; (9) According to the RECIST 1.1 standard, imaging tests show that there are measurable tumor lesions in the brain and extracranium; (10) Laboratory inspection indicators meet the following standards: Neutrophil count >= 1.5x10^9/L; Platelet count >= 100x10^9/L; Hemoglobin >= 90 g/L; Creatinine clearance rate <= 1.5 ULN; The AST and ALT of patients with liver metastases <= 5 ULN, and the AST and ALT of patients without liver metastases <= 2.5 ULN; Total bilirubin <= 1.5 ULN. ...
Trial ID:
Source:
Title:
Bronchial arterial infusion in combination with take icotinib hydrochloride orally for treatment of advanced non-small cell lung cancer
Excerpt:
...EGFR genes mutation; 3. ...
Trial ID:
Source:
Title:
Intercalated Combination of Icotinib and Chemotherapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
Excerpt:
...EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 2. ...
Trial ID:
Source:
Title:
A multicenter, randomized, open-label, phase III clinical trial of Icotinib plus pemetrexed-cisplatin versus pemetrexed-cisplatin as postoperative adjuvant treatment in stage III (N1-N2) non-small cell lung cancer (NSCLC) with EGFR-sensitive mutation
Excerpt:
...Epidermal growth factor receptor( EGFR) sensitive mutation. ...
Trial ID:
Source:
Title:
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
Excerpt:
...- EGFR activating mutation (exon 19 deletion, L858R) is required...
Trial ID:
Source:
Title:
Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI
Excerpt:
...- Histologically or cytologically confirmed stage IIIB/IV lung cancer with EGFR mutation...
Trial ID:
Source:
Title:
Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation
Excerpt:
...- Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery...
Trial ID:
Source:
Title:
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
Excerpt:
...- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation...
Trial ID:
Source:
Title:
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Excerpt:
...- Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have...
Trial ID:
Source:
Title:
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Excerpt:
...- Positive EGFR Mutation...
Trial ID:
Source:
Title:
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
Excerpt:
...- Positive EGFR mutation....
Trial ID:
Source:
Title:
A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
Excerpt:
...- A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation...
Trial ID:
Source:
Title:
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
Excerpt:
...- EGFR activating mutation in exon 19 or 21....
Trial ID:
Source:
Title:
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
Excerpt:
...- Positive EGFR gene mutation (19/21)...
Trial ID:
Source:
Title:
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Excerpt:
...Positive EGFR mutation(19 exon or 21 exon)。...
Trial ID:
Source:
Title:
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma
Excerpt:
...- A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone...
Source:
Title:
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
Excerpt:
...- Positive EGFR mutation（Ex19del or 21L858R）...
Trial ID:
Source:
Title:
Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Excerpt:
...- Positive EGFR Mutation....
Trial ID:
Source:
Title:
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Excerpt:
...- EGFR mutation was detected by Amplification Refractory Mutation System(ARMS) and confirmed to be one of the 2 common EGFR mutations known to be associated with EGFR-TKI （epidermal growth factor receptor tyrosine kinase inhibitors）sensitivity (Ex19del, L858R)....
Source:
Title:
High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
Excerpt:
...- Positive EGFR mutation（Ex19del or 21L858R）....
Trial ID:
Source:
Title:
Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer
Excerpt:
...- Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA...
Trial ID:
Source:
Title:
Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
Excerpt:
...- EGFR activating mutation in exon 19 or 21....
Trial ID:
Less C2 evidence
Source:
Title:
Prognosis prediction of icotinib as targeted therapy for advanced EGFR-positive non-small cell lung cancer patients
Published date:
05/04/2023
Excerpt:
A total of 208 consecutive patients with advanced EGFR-positive NSCLC treated with icotinib were enrolled in this study....PFS events occurred in 175 patients, with a median PFS of 9.9 months (interquartile range, 6.8-14.5). The objective response rate (ORR) was 36.1%, and the disease control rate (DCR) was 67.3%.
DOI:
10.1007/s10637-023-01329-8
Source:
Title:
Adjuvant icotinib versus observation in patients with completely resected EGFR-mutated stage IB NSCLC (GASTO1003, CORIN): a randomised, open-label, phase 2 trial
Published date:
02/03/2023
Excerpt:
Patients with completely resected, EGFR-mutant, stage IB (the 7th edition of TNM staging) NSCLC without adjuvant chemotherapy were randomised (1:1) to receive adjuvant therapy with icotinib….The DFS was significantly longer in the icotinib group than in the observation group, with a hazard ratio (HR) of 0.23 (95% CI, 0.07-0.81; P = 0.013)....Our findings suggested that adjuvant icotinib improved the 3-year DFS in patients with completely resected EGFR-mutated stage IB NSCLC with a manageable safety profile.
DOI:
https://doi.org/10.1016/j.eclinm.2023.101839
Trial ID:
Source:
Title:
369P - Comparison of the efficacy and safety of icotinib with vinorelbine or without vinorelbine as first-line treatment for advanced lung adenocarcinoma in patients with sensitive EGFR mutations: A retrospective study
Published date:
11/28/2022
Excerpt:
...the NSCLC cases that harbored EGFR mutations underwent first-line therapy with icotinib in the presence or absence of vinorelbine....The objective response rate and the disease control rate for the combination group were significantly higher than those for the icotinib only group.
Secondary therapy:
vinorelbine tartrate
Source:
Title:
Icotinib, an EGFR tyrosine kinase inhibitor, as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE)
Published date:
11/10/2022
Excerpt:
The median follow-up time was 39.7 months with a median DFS and overall survival (OS) of 41.4 months (95% CI: 33.6-51.8) and 67.0 months (95% CI: 21.2-not reached [NR]), respectively. The 1-year, 3-year, and 5-year OS rates were 100%, 83.3%, and 61.7%, respectively....Icotinib as adjuvant therapy demonstrated a favorable survival benefit in patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma, indicating that icotinib might be a promising treatment option for this patient population.
DOI:
10.1007/s10637-022-01316-5
Source:
Title:
Adjuvant icotinib versus observation in patients with completely resected, EGFR-mutated, stage IB non–small cell lung cancer (GASTO1003, CORIN): A randomized phase II trial.
Published date:
05/26/2022
Excerpt:
DFS was significantly longer among those in the icotinib arm than among those in the observation arm (hazard ratio: 0.20, 95% confidence interval, 0.04-0.89; P = 0.018). The 3-year DFS for the icotinib and observation arms were 95.3% and 86.7%, respectively....Adjuvant icotinib shows prolonged DFS and acceptable toxicity in patients with completely resected EGFR-mutated stage IB NSCLC.
DOI:
10.1200/JCO.2022.40.16_suppl.8519
Trial ID:
Source:
Title:
5499 - Efficacy of icotinib as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE)
Published date:
03/09/2022
Excerpt:
The phase II ICAPE study demonstrated that 1.5-year adjuvant therapy with icotinib had a favorable survival benefit in patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma with a long median DFS and high 5-year OS rates which is consistent with other icotinib’s study.
Source:
Title:
Different exposure duration of adjuvant icotinib in stage II-IIIA non-small cell lung cancer patients with positive EGFR mutation (ICOMPARE study): A randomized, open-label phase 2 study.
Published date:
05/19/2021
Excerpt:
The median DFS was 48.92 months (95%CI 33.15, 70.11) in 2-year group and 32.89 month (95%CI 26.61, 44.78) in 1-year group, respectively. 2-year icotinib significantly prolonged DFS (HR 0.521, 95%CI 0.278, 0.976; p = 0.039). OS events were observed in 20 patients....2-year adjuvant treatment with icotinib resulted in a significantly lower risk of recurrence than 1-year adjuvant icotinib in patients with stage II-IIIA NSCLC positive EGFR mutations...
DOI:
10.1200/JCO.2021.39.15_suppl.8521
Trial ID:
Source:
Title:
68P - Comparison of first-generation EGFR-TKIs (gefitinib, erlotinib, and icotinib) as adjuvant therapy in resected NSCLC patients with sensitive EGFR mutations
Published date:
03/17/2021
Excerpt:
The median DFS of stage II/III patients in the gefitinib, erlotinib and icotinib group were 36.1 months (95% CI, 23.9–49.4), 42.8 months (95% CI, 29.6–97.8), and 32.5 months (95% CI, 23.9–49.4), respectively...This first and largest real-world study showed that gefitinib, erlotinib, and icotinib demonstrated comparable clinical effectiveness as adjuvant therapy in completely resected patients with EGFR mutated NSCLC.
Source:
Title:
Survival benefit and toxicity profile of adjuvant icotinib for patients with EGFR mutation-positive non-small cell lung carcinoma: a retrospective study
Excerpt:
This was a single-center retrospective study of patients with EGFR mutation-positive NSCLC...The 2-year DFS rate was 86.7%, and the 3-year OS rate was 95.3% with adjuvant icotinib. DFS (P=0.044) and OS (P=0.003)...
DOI:
10.21037/tlcr-20-1214
