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    BIOMARKER:

    EGFR L858R

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor
    Entrez ID:
    1956
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    1d
    COMPEL: A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=98, Active, not recruiting, AstraZeneca | Trial completion date: Jun 2026 --> Jun 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed
    1d
    ML41701: A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors. (clinicaltrials.gov)
    P2, N=22, Completed, National Taiwan University Hospital | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Feb 2026 | Trial primary completion date: Dec 2024 --> Feb 2026
    Trial completion • Trial completion date • Trial primary completion date • IO biomarker
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • pemetrexed
    2d
    Mutation-Specific Response to Ramucirumab in EGFR-Mutated Metastatic NSCLC: Insights From Circulating Cell-Free DNA Profiling (Liquid Biopsy Japan Addendum of RELAY Phase 3 Randomized Study). (PubMed, JTO Clin Res Rep)
    A previous analysis of the RELAY phase 3 liquid biopsy addendum demonstrated suppressed EGFR-activating mutation allele count, increased total cell-free DNA (cfDNA) concentration, and shortened cfDNA fragment size with ramucirumab (RAM) plus erlotinib (ERL) versus placebo (PL) plus ERL in patients with EGFR-mutated NSCLC. This updated analysis revealed differences in total cfDNA concentration and T790M mutation rates between ex19del and L858R. RAM plus ERL may exhibit greater antitumor effects on L858R, supporting the favorable survival benefits observed previously in patients with a L858R.
    P3 data • Journal • Liquid biopsy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    erlotinib • Cyramza (ramucirumab)
    2d
    Efficacy of Adding Immune Checkpoint Inhibition to Chemotherapy, With or Without VEGF Inhibition, in Patients With Advanced EGFR-Mutated NSCLC: A Systematic Review and Meta-Analysis With Reconstructed Individual Patient Data. (PubMed, JTO Clin Res Rep)
    Chemo-immunotherapy with or without VEGFi may produce a modest survival improvement in select patients with EGFR-mutated NSCLC compared with chemotherapy. Identifying biomarkers able to predict a clinically meaningful benefit is warranted.
    Clinical • Retrospective data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR mutation • EGFR L858R
    2d
    Challenges in Diagnosis of Lepidic Subtype in Lung Cancer According to W.H.O Classification: A Case Report. (PubMed, Br J Biomed Sci)
    First-line Osimertinib induced a dramatic clinical and radiological response within days...This case underscores the critical difficulty of diagnosing lepidic-patterned tumors in an oncological emergency. It highlights the necessity of a multidisciplinary approach, combining cytology, radiology, and early molecular testing as a surrogate for traditional histopathology to guide urgent targeted therapy.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • NKX2-1 (NK2 Homeobox 1)
    |
    EGFR mutation • EGFR L858R • EGFR T790M
    |
    Tagrisso (osimertinib)
    3d
    Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • MET overexpression • EGFR exon 20 mutation
    |
    CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody • VENTANA® MET (SP44) RxDx Assay
    |
    Tagrisso (osimertinib) • Emrelis (telisotuzumab vedotin-tllv)
    4d
    Associations between early loss of skeletal muscle and osimertinib trough concentrations in patients with advanced EGFR-mutated NSCLC. (PubMed, Eur J Cancer)
    Early loss of SMI was not associated with osimertinib exposure, yet an independent predictor of shorter OS. Future research should explore whether nutritional interventions to preserve muscle mass improve osimertinib effectiveness.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
    |
    TP53 mutation • EGFR mutation • EGFR L858R
    |
    Tagrisso (osimertinib)
    5d
    RAMOSE: Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=160, Active, not recruiting, Xiuning Le | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Cyramza (ramucirumab)
    7d
    A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jan 2026 --> Jan 2028
    Trial primary completion date
    |
    STK11 (Serine/threonine kinase 11)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Libtayo (cemiplimab-rwlc) • Kevzara (sarilumab)
    8d
    A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=854, Recruiting, AbbVie | Trial completion date: Dec 2031 --> Nov 2036
    Trial completion date • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • telisotuzumab adizutecan (ABBV-400)
    8d
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=320, Recruiting, BioNTech SE | N=156 --> 320
    Enrollment change • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • RET rearrangement
    |
    Tagrisso (osimertinib) • carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    9d
    RAISE: The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Hunan Province Tumor Hospital | Not yet recruiting --> Recruiting | Trial completion date: Jun 2027 --> Apr 2026 | Trial primary completion date: Dec 2026 --> Mar 2026
    Enrollment open • Trial completion date • Trial primary completion date • Real-world evidence
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib)