marked.bio

EGFR TKI (incl. exon 20 insertions) · small molecule

PLB1004

9 active trials across 3 of our biomarkers, targeting EGFR. Not approved for any biomarker on marked.bio yet.

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 7 8 Phase 3
EGFR exon 20 insertion 4 4 Phase 3
HER2 (ERBB2) activating mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of PLB1004.

  1. Avistone Biotechnology 8
  2. Beijing Pearl Biotechnology 1

Trials

9 of 10 trials shown

  1. Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure

    Not yet recruiting Phase 3 Avistone Biotechnology Started 2025Primary completion 2027-12 NCT06970782

    vebreltinibPLB1004pemetrexedcarboplatincisplatin

    Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

  2. Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

    Enrolling by invitation Phase 3 Avistone Biotechnology Started 2023Primary completion 2028-06 NCT06281964

    PLB1004pemetrexedcarboplatincisplatinsintilimab

    Tumor tissue is positive for EGFR Ex20ins as documentally confirmed by next-generation sequencing (NGS) testing or written confirma…

    EGFR exon 20 insertionNon-Small-Cell Lung Cancer

  3. A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

    Not yet recruiting Phase 1/2 Beijing Pearl Biotechnology Started 2026Primary completion 2029-12 NCT07285148

    PLB1004osimertinib FDA EU

    Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples …

    EGFR exon 19 deletion / L858REGFR exon 20 insertionNon-Small Cell Lung Cancer, EGFR Mutation, Metastatic Lung Cancer, MET Alteration

  4. Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

    Recruiting Phase 2 Avistone Biotechnology Started 2026Primary completion 2026-11 NCT07336732

    PLB1004

    …ublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

  5. Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

    Not yet recruiting Phase 1/2 Avistone Biotechnology Started 2025Primary completion 2028-03 NCT07063329

    PLB1004

    Patients with other EGFR mutations such as EGFR exon 20 insertion: They must have received platinum-based chemotherapy.

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

  6. Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

    Recruiting Phase 2 Avistone Biotechnology Started 2024Primary completion 2026-10 NCT06574347

    vebreltinibosimertinib FDA EUPLB1004

    Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

  7. Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

    Recruiting Phase 1/2 Avistone Biotechnology Started 2023Primary completion 2026-12 NCT06343064

    vebreltinibPLB1004

    EGFR mutations, including exon 19 deletion and exon 21 L858R.

    EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer

  8. A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

    Active, not recruiting Phase 2 Avistone Biotechnology Started 2023Primary completion 2025-03 NCT06015503

    PLB1004

    Participants with EGFR ex20ins mutation.

    EGFR exon 20 insertionNSCLC (Non-small Cell Lung Cancer)

  9. A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer

    Recruiting Phase 1 Avistone Biotechnology Started 2024Primary completion 2028-02 NCT06046495

    PLB1004

    Have a documented EGFR mutation by a local test in tissue or plasma;

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer