A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502959-54-00

Acronym

DZD2022E0005

Enrollment

Registered

2023-06-09

Start date

2023-09-26

Completion date

Unknown

Last updated

2025-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Brief summary

Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1

Detailed description

1. OS (key secondary endpoint); PFS assessed by Investigator assessment per RECIST 1.1; Confirmed ORR, DoR, DCR, and percentage of tumor size change assessed by BICR and Investigator per RECIST 1.1, 2. AE/SAE per CTCAE 5.0; Laboratory test; Vital signs; ECG; ECHO/ MUGA scan; PFT, 3. Plasma concentration of DZD9008 and metabolite(s), Data from this study may form part of a pooled analysis with data from other studies., 4. EGFR Exon20ins mutation status in tumor tissues, and the correlations with clinical efficacy of drugs, 5. EGFR Exon20ins mutation status in plasma ctDNA collected before drug medication, and the correlations with clinical efficacy of drugs

Interventions

DRUGSunvozertinib

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGCarboplat onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1	—

Secondary

Measure	Time frame
1. OS (key secondary endpoint); PFS assessed by Investigator assessment per RECIST 1.1; Confirmed ORR, DoR, DCR, and percentage of tumor size change assessed by BICR and Investigator per RECIST 1.1, 2. AE/SAE per CTCAE 5.0; Laboratory test; Vital signs; ECG; ECHO/ MUGA scan; PFT, 3. Plasma concentration of DZD9008 and metabolite(s), Data from this study may form part of a pooled analysis with data from other studies., 4. EGFR Exon20ins mutation status in tumor tissues, and the correlations with clinical efficacy of drugs, 5. EGFR Exon20ins mutation status in plasma ctDNA collected before drug medication, and the correlations with clinical efficacy of drugs	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026