Evidence Level:Sensitive: B - Late Trials
New
Title:
FP14.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study
Excerpt:EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed...In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001).
Evidence Level:Sensitive: B - Late Trials
New
Title:
JICC01.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study
Excerpt:53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively....Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile.
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:
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....
More C2 evidence

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:
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Clinical Study on Adjuvant Targeted Therapy with EGFR Mutation after Surgery for Stage IA Non-small Cell Lung Cancer
Excerpt:...Pathologically confirmed non-small cell lung cancer (NSCLC) with standard radical lung cancer surgery (lobectomy or segmentectomy + hilar and mediastinal lymph node dissection/sampling); b. Postoperative pathological staging with high-risk pathological factors such as papillary/micropapillary/solid/mucinous components, with or without complex glandular structures in stage IA NSCLC; c. Positive ct-DNA test results after surgery and before adjuvant therapy (4 weeks post-surgery); d. Age ≥18 years and ≤75 years; e. ECOG or PS score of 0 or 1; f. The patient's primary NSCLC has classical EGFR mutations (EGFR 19 Del or 21 L858R); g. The diagnosed patient has not previously received lung cancer-related chemotherapy, radiotherapy, or targeted therapy; h. Normal function of major organs; i. Women of childbearing age or male subjects with partners of childbearing age must take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period; complete postoperative recovery with no signs of tumor recurrence on imaging tests....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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)....
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:
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)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
Excerpt:...- Positive EGFR mutation(Ex19del or 21L858R)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
Evidence Level:Sensitive: C2 – Inclusion Criteria
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...
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:
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....
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)....
Less C2 evidence

Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy and Failure Patterns of Early SBRT to the Primary Tumor in Advanced EGFR-Mutation-Positive Lung Cancer with EFGR-TKI Treatment: A Prospective, Single Arm, Phase II Study
Excerpt:All patients were administered a first-generation EGFR-TKI (icotinib 125 mg tid or gefitinib 250 mg qd, orally)....The PFS of subgroups in number of metastases >5 vs. <5 and EGFR mutation L858R vs. 19-del were 11.13 months vs. 16.33 months (HR 0.45, 95% CI (0.23–0.91), p = 0.016) and 13.43 months vs. 26.69 months (HR 0.23, 95% CI (0.12–0.46), p = 0.0017), respectively (Figure 3)....early-phase SBRT for the primary lung tumor combined with EGFR-TKI followed by RT may be an alternative choice for advanced NSCLC harboring the EGFR mutation.
DOI:https://doi.org/10.3390/life12121954
Evidence Level:Sensitive: C3 – Early Trials
Title:
Primary lesion radiotherapy during first-line icotinib treatment in EGFR-mutated NSCLC patients with multiple metastases and no brain metastases: a single-center retrospective study
Excerpt:EGFR-mutant NSCLC patients diagnosed with limited multiple metastases were treated with first-line icotinib….Subgroup analysis showed that the results were statistically significant with 14.7 and 11.5 months for the 19del mutation (HR 0.20, 95% CI 0.10–0.40, P < 0.001) and 12.9 and 9.9 months for the L858R mutation (HR 0.25, 95% CI 0.13–0.48, P < 0.001)....This study suggests that CPRT is a viable option for patients with EGFR-sensitive mutations in NSCLC with limited multiple metastases during first-line icotinib treatment, which can significantly improve PFS with acceptable toxicities.
DOI:https://doi.org/10.1007/s00066-022-01971-w
Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy of Icotinib, an EGFR Tyrosine Kinase Inhibitor in Non-Small Cell Lung Cancer Patients with Exon 19 Deletion and Exon 21 L858R: A Retrospective Analysis in China
Excerpt:We retrospectively assessed the clinical effects of first-line icotinib on advanced NSCLC patients with 2 classic EGFR mutations….Patients with 19-Del had a higher response rate (ORR; 67.8 vs. 62.1%; p = 0.0039) and disease control rate (98.5 vs. 97.2%; p = 0.0223) than those with 21-L858R mutation.
Evidence Level:Sensitive: C3 – Early Trials
Title:
First-Line EGFR-TKIs Treatment in Stage I Non-Small-Cell Lung Cancer Patients Harboring EGFR Gene Mutations with Postoperative Intrapulmonary Recurrence
Excerpt:We investigated 30 stage I non-small-cell lung cancer patients harboring EGFR gene mutations with postoperative intrapulmonary recurrence....The median PFS observed in patients who underwent icotinib treatment was significantly longer than in patients who underwent gefitinib treatment (30.5 months vs 12.0 months, p = 0.005). There were no statistical differences in median PFS between patients with tumors harboring exon 21 mutation and exon 19 deletion...
Evidence Level:Sensitive: C4 – Case Studies
Title:
Complete remission following icotinib administration in advanced ectopic thymic carcinoma patient harbouring EGFR exon 19 deletion
Excerpt:We present here the case of a 61-year-old man with advanced posterior mediastinum thymic squamous cell carcinoma….ARMS-PCR analysis revealed an EGFR exon 19 deletion in the patient. The patient subsequently received icotinib treatment and achieved complete remission for 3 years.