Conmana (icotinib) / Betta Pharma - LARVOL DELTA

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. (PubMed, Lancet Respir Med) - P3 | "Our 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."

Clinical • Journal • P3 data • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • EGFR

Concurrent icotinib and definitive radiotherapy followed by detection of an EGFR exon 20 insertion at disease progression in unresectable stage III EGFR S768I-mutant lung adenocarcinoma: a case report. (PubMed, Front Oncol) - "Subsequent treatment with afatinib, ivonescimab plus chemotherapy, and sunvozertinib was selected according to dynamic molecular profiling. More importantly, it highlights the value of repeat biopsy and comprehensive genomic profiling for interpreting molecular changes at disease progression and guiding subsequent individualized treatment in patients with uncommon EGFR mutations. However, these observations are derived from a single case and require validation in larger prospective studies."

Journal • Lung Adenocarcinoma • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

EGFR-TKIs plus Stereotactic Body Radiation Therapy (SBRT) for Stage IV Non-small Cell Lung Cancer (NSCLC): a prospective, multicenter, randomized, controlled phase II study. (PubMed, Radiother Oncol) - P2 | "The addition of SBRT significantly delayed the onset of acquired resistance to EGFR-TKIs and prolonged the PFS and OS of patients. Radiotherapy of the primary lesion alone might be superior to metastatic sites. Further confirmatory studies are needed to confirm our findings."

Journal • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated NSCLC. (PubMed, J Natl Cancer Inst) - P3 | "As compared to a first-line TKI alone, addition of up-front local therapy using RT statistically significantly improved PFS and OS for EGFR-mutated NSCLC."

Journal • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • EGFR

Icotinib plus chemotherapy as neoadjuvant treatment for resectable stage II-IIIB EGFR-mutant lung adenocarcinoma: a phase II study (NEOIPOWER). (PubMed, Lung Cancer) - P2 | "Neoadjuvant icotinib combined with chemotherapy did not meet its primary endpoint for MPR rate in resectable stage II-IIIB EGFRm lung adenocarcinoma, but demonstrated a manageable safety profile."

Journal • P2 data • Hematological Disorders • Leukopenia • Lung Adenocarcinoma • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Evaluation of Clinical Outcomes of Icotinib in Patients With Clinically Diagnosed Advanced Lung Cancer With EGFR-Sensitizing Variants Assessed by Circulating Tumor DNA Testing: A Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This prospective phase 2 nonrandomized clinical trial suggests that for patients with clinically diagnosed advanced lung cancer with unknown pathological status, ctDNA-based EGFR genotyping could help decision-making in particular clinical situations, while still warranting future larger-scaled real-world exploration. ClinicalTrials.gov Identifier: NCT03346811."

Circulating tumor DNA • Clinical • Clinical data • Journal • P2 data • Lung Cancer • Oncology • Solid Tumor • EGFR

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). (PubMed, ESMO Open) - P2 | "Two-year adjuvant icotinib was shown to significantly improve DFS and provide an OS benefit in EGFR-mutant, stage II-IIIA lung adenocarcinoma patients compared with 1-year treatment in this exploratory phase II study."

Journal • P2 data • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Clinical utility of molecular residual disease detection in early-stage resected EGFR-mutated non-small cell lung cancer. (PubMed, Nat Commun) - "Here we report the MRD analysis from the phase 3 EVIDENCE trial, which includes patients with stage II-IIIA resected EGFR-mutated NSCLC who have received either adjuvant icotinib or chemotherapy...Longitudinal MRD shows a 91.3% negative predictive value, with a median lead time of 169 days prior to clinical recurrence. Among serial monitoring timepoints, MRD status at 24 weeks post-randomization demonstrates the highest prognostic value."

Biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer (clinicaltrials.gov) - P=N/A | N=2572 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

New trial • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Clinical Efficacy and Safety of Icotinib as Adjuvant Therapy for Resected Stage IA Lung Adenocarcinoma: A Real-World Study (IASLC-WCLC 2026) - "No patient discontinued EGFR-TKI therapy owing to treatment-related severe adverse events. Conclusions : Compared with clinical observation, adjuvant icotinib was associated with a significant improvement in DFS among patients with stage IA lung adenocarcinoma and exhibited a favorable safety and tolerability profile."

Clinical • Real-world • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Adjuvant icotinib of 12 months versus observation as adjuvant therapy for completely resected EGFR-mutated stage IB non-small-cell lung cancer: 5-year update from CORIN (GASTO1003). (ASCO 2025) - P2 | "In this 5-year update analysis from CORIN, adjuvant icotinib continues to demonstrate durable DFS benefit versus observation in resected EGFR-mutated stage IB NSCLC, with a manageable safety profile. Icotinib sustained OS separation versus observation over time and demonstrated a marginal OS benefit, which is limited by the small sample size and wide CIs. Adjuvant icotinib for 1 year provides a treatment option for these patients."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Adjuvant Icotinib Versus Osimertinib in EGFR-Mutated Resected Non-Small Cell Lung Cancer: A Chinese, Real-World Multicenter Cohort Study (IASLC-WCLC 2026) - P=N/A | "Icotinib demonstrated higher 3-year DFS in Ex19del subgroup, while osimertinib was associated with lower CNS recurrence and slightly higher grade ≥3 AEs. Both are effective selection may be guided by mutation subtype and CNS risk."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study. (PubMed, Lancet Respir Med) - P2/3 | "Befotertinib demonstrated superior efficacy compared with icotinib in first-line treatment for patients with EGFR mutation-positive NSCLC. Although serious adverse events were more common in the befotertinib than the icotinib arm, the safety profile of befotertinib was manageable overall."

Journal • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Befotertinib vs Icotinib as First-Line Treatment for EGFR-mutated Advanced NSCLC: Final Overall Survival Analysis of the Phase III Study (IASLC-WCLC 2026) - "The safety profile was consistent with previous reports, and no new safety signals were identified. Conclusions : Befotertinib demonstrated sustained benefits in PFS and DOR with a manageable safety profile; OS was not statistically different between arms, likely influenced by the sample size and the higher usage of subsequent third-generation EGFR TKIs in the icotinib arm."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. (ASCO 2024) - P3 | "Adjuvant icotinib for 12 months and 6 months provide a significant DFS and OS benefit compared with observation in patients with completely resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile. Nevertheless, 12 months of icotinib had no additional benefit compared with 6 months."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Three-year adjuvant treatment of icotinib in stage II-IIIA EGFR-mutated lung adenocarcinoma (ICWIP): a randomized, double-blind, placebo-controlled phase 3 trial. (PubMed, Signal Transduct Target Ther) - P3 | "Treatment-related adverse events occurred in 48.5% (32/66) and 23.2% (16/69) of the patients in the icotinib group and the placebo group, respectively. Three-year adjuvant treatment with icotinib significantly improved DFS compared to placebo in patients with completely resected stage II-IIIA EGFR-mutated lung adenocarcinoma who had completed four cycles of adjuvant chemotherapy, with a manageable safety profile."

Clinical • Journal • P3 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety of almonertinib as adjuvant therapy in stage II-IIIA EGFR-mutant non-small cell lung cancer: a retrospective study. (PubMed, Front Med (Lausanne)) - "To compare the efficacy and safety of adjuvant almonertinib versus icotinib in patients with resected stage II-IIIA epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). A numerical trend of reduced CNS metastasis was observed, but limited CNS events preclude firm conclusions regarding CNS protective activity. A tentative early OS survival trend favoring almonertinib was observed, but OS data remain immature with limited death events; long-term follow-up is needed to verify this potential survival benefit."

Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sequential EGFR T790M, MET c.3010C>G-Associated Exon 14 Alteration, and RET-CCDC6 Fusion in EGFR-Mutant NSCLC: A Case Report. (PubMed, Thorac Cancer) - "First-line icotinib produced a partial response (PR) with progression-free survival (PFS) of 7 months...After renewed progression, almonertinib plus savolitinib achieved another PR for 8 months, supporting MET-dependent bypass resistance...Because selective RET inhibition was initially unaffordable, the patient received pemetrexed-carboplatin plus continued almonertinib, followed by selpercatinib plus almonertinib...At the latest follow-up in January 2026, the patient remained alive nearly 50 months after diagnosis. This case illustrates clonal evolution under treatment pressure and highlights three practical lessons: repeat molecular testing at each clinically meaningful progression, matched combination targeted therapy for actionable bypass alterations, and local ablative radiotherapy for oligoprogression."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCDC6 • EGFR • MET • TP53

Clinical Efficacy and Safety of Icotinib as Adjuvant Therapy for Resected Stage IA Lung Adenocarcinoma: A Real-world Study. (PubMed, Clin Lung Cancer) - "Compared with clinical observation, adjuvant icotinib was associated with a significant improvement in DFS among patients with stage IA lung adenocarcinoma and exhibited a favorable safety and tolerability profile."

Journal • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Too Old for Surgery? A Case Report of an Octogenarian Patient With Locally Advanced Lung Cancer Achieving Long-Term Survival via Bilobectomy Followed by Adjuvant Targeted Therapy. (PubMed, Cancer Rep (Hoboken)) - "Age alone is not a contraindication for lung cancer surgery and octogenarian patients may tolerate surgical resection following careful preoperative evaluation. Adjuvant targeted therapy may prolong survival in octogenarian lung cancer patients harboring oncogenic driving gene mutation after surgery."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Case Report: Short-term disease control with subsequent icotinib therapy in EGFR L858R/C797S, T790M-negative lung adenocarcinoma after osimertinib resistance. (PubMed, Front Oncol) - "She was subsequently treated with icotinib 125 mg tid, achieving stable disease for 6 months. This case suggests that first-generation EGFR-TKI subsequent therapy may provide short-term disease control in this rare molecular context."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pleural Fluid Cytology Detects Small Cell Carcinoma Transformation in EGFR-Mutant Lung Adenocarcinoma: A Case Report. (PubMed, Diagn Cytopathol) - "Integrated cytological and molecular analysis of pleural fluid can provide compelling evidence supporting small cell transformation in EGFR-mutant lung adenocarcinoma. The shared EGFR mutation between the primary and transformed tumors is consistent with clonal evolution. This minimally invasive approach offers a practical alternative to tissue re-biopsy for monitoring acquired resistance to EGFR-TKIs."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR • NCAM1 • NKX2-1

Survival Prediction in Patients With Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer With Bone Metastases Receiving Icotinib Therapy: A Retrospective Observational Study. (PubMed, Technol Cancer Res Treat) - "Calibration plots and DCA demonstrated acceptable performance and potential clinical relevance.ConclusionsAlbumin, LDH, and PLR predict PFS in EGFR-mutated NSCLC with BoM treated with icotinib. The proposed nomogram may assist in preliminary risk stratification in this specific population."

Journal • Observational data • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Ivonescimab monotherapy in an elderly patient with EGFR-TKI-resistant advanced lung adenocarcinoma and pericardial effusion: a case report and literature review. (PubMed, Front Immunol) - "Disease progression was observed after four cycles of chemotherapy (docetaxel plus nedaplatin) and subsequent EGFR-TKI therapy (icotinib and later furmonertinib combined with anlotinib). This case suggests that ivonescimab monotherapy can achieve disease control with an acceptable safety profile in an elderly, heavily pretreated NSCLC patient with EGFR-TKI resistance and malignant pericardial effusion. It may represent a viable treatment option for this challenging population."

IO biomarker • Journal • Monotherapy • Review • Cardiovascular • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor • GRP-10

Exosomal circ_0097112 drives icotinib resistance through activating RAF/MAPK signaling in lung adenocarcinoma. (PubMed, Cell Signal) - "This molecular event consequently activates downstream RAF/MAPK signaling, attenuating apoptosis while promoting cellular proliferation and drug resistance. Collectively, this study reveals the pivotal involvement of the circ_0097112/UPF1/NRAS axis in driving EGFR-TKI resistance in LUAD and offers a new theoretical basis for targeting circ_0097112 to reverse EGFR-TKI resistance."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NRAS • UPF1