Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
More C2 evidence

Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Treatment of Gefitinib or Icotinib in lung adenocarcinoma of stage IA with micropapillary or solid
Excerpt:...Patients with single primary lung cancer, a full set of tumor marker tests, blood biochemistry tests and related routine blood tests, enhanced CT of the chest, CT or ultrasound of the abdomen (liver, gallbladder, pancreas, spleen, kidneys, and adrenal glands), ultrasound of the cervical and supraclavicular lymph nodes, MR of the head or CT of the head, and whole-body bone imaging were all perfected to exclude metastasis before surgery; Complete surgical resection of the tumor with guaranteed negative margins (R0), the patient's surgical approach can be lobectomy, segmental resection, wedge resection of the lung, and regional lymph node sampling;Postoperative pathologically confirmed stage I lung adenocarcinoma (according to the 8th edition of the AJCC TNM staging system for lung cancer) with micropapillary or solid-type components;and had a confirmed EGFR mutation(exon 19 deletion or exon 21 L858R);Eligible patients were between 18 and 75 years of age; had an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
Excerpt:...- EGFR activating mutation in exon 19 or 21....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Excerpt:...Positive EGFR mutation(19 exon or 21 exon)。...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Excerpt:...- Positive EGFR Mutation....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
Excerpt:...- Patients must harbor sensitive EGFR gene mutation (19/21)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
Excerpt:...Sensitive EGFR gene mutation(19/21) 5....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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);...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Excerpt:...- Positive EGFR Mutation...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Less C2 evidence

Evidence Level:Sensitive: C3 – Early Trials
Title:
NEOIPOWER: Icotinib plus Chemotherapy as Neoadjuvant Treatment for Resectable Stage II-IIIB EGFR-mutant Lung Adenocarcinoma
Excerpt:NEOIPOWER is an ongoing, single-arm, phase II study (NCT05104788). Eligible treatment-naïve patients (aged 18-75 years) had histologically/cytologically confirmed, resectable, stage II-IIIB, EGFRm lung adenocarcinoma, ECOG PS ≤1, and at least one measurable lesion. Patients received 8 weeks of oral icotinib (125 mg thrice daily) plus 2 cycles (3 weeks/cycle) of chemotherapy (pemetrexed 500 mg/m2 and carboplatin AUC5 on day 1), followed by surgical resection....Interim analysis from this study indicated neoadjuvant icotinib plus chemotherapy as an effective and feasible treatment in patients with resectable stage II-IIIB EGFRm NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study)
Excerpt:...this multicenter, randomized, open-label, phase II trial, eligible patients aged 18-75 years with EGFR-mutant, stage II-IIIA lung adenocarcinoma….Median DFS was 48.9 months [95% confidence interval (CI) 33.1-70.1 months] in the 2-year group and 32.9 months (95% CI 26.6-44.8 months) in the 1-year group [hazard ratio (HR) 0.51; 95% CI 0.28-0.94; P = 0.0290]. Median OS for patients was 75.8 months [95% CI 64.4 months-not evaluable (NE)] in the 2-year group and NE (95% CI 66.3 months-NE) in the 1-year group (HR 0.34; 95% CI 0.13-0.95; P = 0.0317)....Two-year adjuvant icotinib was shown to significantly improve DFS and provide an OS benefit in EGFR-mutant, stage II-IIIA lung adenocarcinoma patients.
DOI:10.1016/j.esmoop.2023.101565