marked.bio

EGFR exon 20 insertion TKI · small molecule

zipalertinib

5 active trials across 2 of our biomarkers, targeting EGFR exon 20. Not approved for any biomarker on marked.bio yet.

Also known as TAS6417, CLN-081.

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 20 insertion 5 5 Phase 3
EGFR exon 19 deletion / L858R 4 4 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of zipalertinib.

  1. Taiho Pharmaceutical 3
  2. Cullinan Therapeutics 1

Trials

5 of 5 trials shown

  1. A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

    Recruiting Phase 3 Taiho Pharmaceutical Started 2025Primary completion 2029-10 NCT07128199

    zipalertinib

    …Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

    EGFR exon 19 deletion / L858REGFR exon 20 insertionLung Cancer, Adjuvant, Post-surgical, EGFR

  2. REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

    Active, not recruiting Phase 3 Taiho Pharmaceutical Started 2023Primary completion 2027-05 NCT05973773

    zipalertinib

    Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation

    EGFR exon 19 deletion / L858REGFR exon 20 insertionAdvanced or Metastatic NSCLS With Exon 20 Insertion Mutation

  3. Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Jonsson Comprehensive Cancer Center Starts 2027Primary completion 2029-06 NCT07229339

    carboplatinpemetrexedzipalertinib

    …llment with EGFR Ex20Ins-mutated (addition of 1 or more amino acids) or uncommon/compound EGFR mutations (E709X, G719X, L747X, S758I, and/or L861Q) in tumor tissue or blood

    EGFR exon 19 deletion / L858REGFR exon 20 insertionLung Non-Squamous Non-Small Cell Carcinoma

  4. A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

    Recruiting Phase 2 Taiho Pharmaceutical Started 2023Primary completion 2028-08 NCT05967689

    zipalertinibCYP CocktailTransporter Cocktail

    common EGFRmt (eg, ex19del or L858R)

    EGFR exon 19 deletion / L858REGFR exon 20 insertionAdvanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

  5. A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Cullinan Therapeutics Started 2019Primary completion 2025-10 NCT04036682

    zipalertinib

    Documented EGFR ex20ins mutation demonstrated by a validated test listed in Section 9.7 and performed in a Clinic…

    EGFR exon 20 insertionNon Small Cell Lung Cancer, EGFR Exon 20 Mutation