marked.bio

EGFR TKI (3rd generation) · small molecule

befotertinib

9 active trials across 2 of our biomarkers, targeting EGFR. Not approved for any biomarker on marked.bio yet.

Also known as D-0316.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 9 12 Phase 3
EGFR exon 20 insertion 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of befotertinib.

  1. Betta Pharmaceuticals 3

Trials

9 of 12 trials shown

  1. Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

    Recruiting Phase 3 Betta Pharmaceuticals Started 2023Primary completion 2028-04 NCT06041776

    befotertinibicotinib

    …bors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-09-22Non-Small Cell Lung Cancer, EGFR Sensitive Mutation, Adjuvant Therapy

  2. ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy

    Not yet recruiting Phase 2 Hebei Medical University Fourth Hospital Started 2026Primary completion 2030-02 NCT07410611

    befotertinib

    Presence of an EGFR sensitizing mutation (19Del or 21L858R);

    EGFR exon 19 deletion / L858RPatients With Advanced Oligometastatic Non-small Cell Lung Cancer (NSCLC) Who Have Tested Positive for EGFR Mutations Confirmed by Histopathological Examination

  3. Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

    Recruiting Phase 2 Betta Pharmaceuticals Started 2025Primary completion 2028-11 NCT07181499

    befotertinibpemetrexedcarboplatin

    …FR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);

    EGFR exon 19 deletion / L858RNSCLC, Adjuvant Drug Therapy, EGFR

  4. Evaluation of the Efficacy and Safety of Befotertinib Combined With Bevacizumab as First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer With Brain Metastases: A Single-Arm, Open-Label, Prospective Phase II Clinical Study

    Active, not recruiting Phase 2 Li-kun Chen Started 2024Primary completion 2028-02 NCT06728865

    befotertinibbevacizumab

    Baseline evaluation confirming the presence of EGFR-sensitizing mutations (19del/L858R) via first- or second-generation sequencing.

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer (NSCLC), EGFR Mutation-Positive Lung Cancer, Brain Metastases, Leptomeningeal Metastases

  5. Phase II Clinical Study of Befotertinib in EGFR Non-classical Mutant NSCLC

    Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2024Primary completion 2027-06 NCT06863506

    befotertinib

    Documented EGFR mutations: Cohort 1 (G719X/L861Q/S768I) or Cohort 2 (exon 20 insertion)

    EGFR exon 19 deletion / L858REGFR exon 20 insertionNSCLC (Non-small Cell Lung Cancer)

  6. Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

    Recruiting Phase 2 Peng Zhang Started 2024Primary completion 2025-12 NCT06755684

    befotertinibbevacizumab

    …ombined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

    EGFR exon 19 deletion / L858REGFR, Non-Small Cell Lung Cancer, Locally Advanced Non-Small Cell Lung Cancer, Pemetrexed

  7. Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2026-07 NCT06517953

    icotinibbefotertinib

    Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-07-25Non-small Cell Lung Cancer Metastatic, EGFR G719X, EGFR L861Q, EGFR S768I

  8. Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation

    Not yet recruiting Phase 1 Betta Pharmaceuticals Started 2023Primary completion 2028-11 NCT06015568

    MCLA-129befotertinib

    …astatic NSCLC that is not suitable for radical surgery or radiotherapy, and harbored EGFR exon 19 deletion or exon 21 L858R mutation( either alone or in combination with other EGFR mutations) in N…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-08-29Non-Small Cell Lung Cancer、EGFR Sensitive Mutation

  9. Therapy for Advanced NSCLC With EGFR 19delins Mutation

    Not yet recruiting Early Phase 1 Fuzhou General Hospital Started 2026Primary completion 2030-10 NCT07458919

    icotinibgefitinib FDA EUbefotertinibosimertinib FDA EUfurmonertinib

    Epidermal growth factor receptor (EGFR) exon 19 deletion-insertion mutation (19delins) documented by testing of tumor tissue or plasma samples usi…

    EGFR exon 19 deletion / L858RLung Cancer