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EGFR exon 20 insertion TKI · small molecule

sunvozertinib

15 active trials across 9 of our biomarkers, targeting EGFR exon 20. 1 active approval for a biomarker on marked.bio.

Also known as DZD9008, Zegfrovy.

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

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
sunvozertinib
FDA, 2025
locally advanced or metastatic, EGFR exon 20 insertion, after platinum FDA accelerated approval 02/07/2025; companion test Oncomine Dx Express Test. Source
Zegfrovy 		EGFR exon 20 insertion NSCLC Approved 2025 accelerated Not approved

WU-KONG1B single-arm, 85 patients
Response 46% (35-57)Lasting 11.1 months

Serious side effects 41%Stopped for side effects 8%Fatal 2.2%

Trial details and side effects
Patients
EGFR exon 20 insertion NSCLC after platinum (NCT03974022)
Most common side effects
diarrhoea 73%, rash 60%, decreased appetite 52%, fatigue 41%, stomatitis 40%, vomiting 35%, nausea 32%, paronychia 30%, constipation 27% (91 patients)
Notes
FDA approval summary (2025), 200 mg dose. Side effects: Zegfrovy US label, section 6 (WU-KONG1B, 200 mg).
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 20 insertion 9 9 Phase 3
EGFR exon 19 deletion / L858R 8 10 Phase 1/2
ALK fusion 1 1 Phase 2
BRAF V600E 1 1 Phase 2
HER2 (ERBB2) activating mutation 1 2 Phase 1/2
KRAS G12C 1 1 Phase 2
NTRK1/2/3 fusion 1 1 Phase 2
RET fusion or mutation 1 1 Phase 2
ROS1 fusion 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of sunvozertinib.

  1. Dizal Pharmaceuticals 6
  2. Dizal (Jiangsu) Pharmaceutical 1

Trials

15 of 17 trials shown

  1. A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery

    Recruiting Phase 3 Dizal (Jiangsu) Pharmaceutical Started 2025Primary completion 2029-09 NCT07182682

    sunvozertinib FDAMatching Placebo

    Have documented EGFR exon20ins (Cohort 1) or EGFR PACC mutations (Cohort 2) from a local Clinical Laboratory Improvement…

    EGFR exon 20 insertionNon-Small Cell Lung Cancer

  2. A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

    Active, not recruiting Phase 3 Dizal Pharmaceuticals Started 2022Primary completion 2026-01 NCT05668988

    sunvozertinib FDApemetrexedcarboplatin

    Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation

    EGFR exon 20 insertionNon-small Cell Lung Cancer

  3. Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

    Recruiting Phase 1/2 Dizal Pharmaceuticals Started 2025Primary completion 2028-06 NCT07079475

    DZD6008sunvozertinibosimertinib FDA EU

    Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  4. Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC

    Recruiting Phase 2 Tang-Du Hospital Started 2025Primary completion 2026-12 NCT06864624

    sunvozertinib FDA

    EGFR exon 20 insertion mutation confirmed by an approved local laboratory.

    EGFR exon 20 insertionNSCLC

  5. A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer

    Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2024Primary completion 2026-01 NCT06182761

    sunvozertinibanlotinib

    EGFR sensitive mutations confirmed by accredited local laboratories， including 19del、L858R and T790M。

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-12-27NSCLC

  6. Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024Primary completion 2025-10 NCT06348927

    sunvozertinibanlotinib

    EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, includi…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-19Non-Small Cell Lung Cancer

  7. Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024Primary completion 2025-12 NCT06355609

    sunvozertinibanlotinib

    EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, includi…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-20Non-small Cell Lung Cancer

  8. Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

    Recruiting Phase 1/2 Sichuan University Started 2024Primary completion 2027-12 NCT06195189

    sunvozertinibChemotherapy

    EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

  9. Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.

    Active, not recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2024Primary completion 2030-05 NCT07274761

    sunvozertinib FDA

    4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two we…

    EGFR exon 20 insertionPotentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer

  10. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06563999

    sunvozertinib FDAcrizotinibpralsetiniblarotrectinibsavolitinibpyrotinibdabrafenibtrametinibglecirasibensartinib

    Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK …

    EGFR exon 20 insertionKRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionLung Cancer Stage III, Mutation

  11. DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)

    Recruiting Phase 2 Dizal Pharmaceuticals Started 2023Primary completion 2025-12 NCT06276283

    sunvozertinib FDAbevacizumab

    …A is not limited to a specific EGFR mutation, and Part B only includes patients with EGFR Exon20ins.

    EGFR exon 20 insertionNon-small Cell Lung Cancer

  12. Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)

    Active, not recruiting Phase 2 Dizal Pharmaceuticals Started 2021Primary completion 2022-10 NCT05712902

    sunvozertinib FDA

    Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laborat…

    EGFR exon 20 insertionNon-Small Cell Lung Cancer

  13. Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

    Active, not recruiting Phase 1/2 Dizal Pharmaceuticals Started 2019Primary completion 2024-07 NCT03974022

    sunvozertinib

    …ocumented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.

    EGFR exon 19 deletion / L858REGFR exon 20 insertionHER2 (ERBB2) activating mutationNon-Small Cell Lung Cancer

  14. A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

    Recruiting Phase 1 Dizal Pharmaceuticals Started 2025Primary completion 2027-09 NCT06905197

    DZD6008sunvozertinib

    For Part A monotherapy cohorts and all cohorts of Part B, EGFR sensitizing mutations (Exon19del and/or L858R) are required.

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

  15. Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)

    Recruiting No phase Peking Union Medical College Hospital Started 2021Primary completion 2026-12 NCT05559645

    sunvozertinib

    in Cohort 5 with EGFR sensitizing mutation

    EGFR exon 19 deletion / L858REGFR exon 20 insertionNon Small Cell Lung Cancer