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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

NCT07182682 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-12-15

No results posted yet for this study

Summary

To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.

Conditions

Interventions

DRUG

sunvozertinib

Participants will receive oral administration of sunvozertinib 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event \[AE\], completion of 3-year \[156-week\] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).

DRUG

Matching Placebo

Participants will receive oral administration of placebo 200 mg QD following randomization, with each treatment cycle defined as 21 days, until meeting any treatment discontinuation criteria (i.e, objective disease recurrence, intolerable adverse event \[AE\], completion of 3-year \[156-week\] treatment period, study termination, death, treatment or study withdrawal by participants, whichever occurs first).

Sponsors & Collaborators

  • Dizal (Jiangsu) Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhou · Shanghai East Hospital

  • Wang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2029-09-30
Completion
2031-01-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182682 on ClinicalTrials.gov