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

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.

Trial Details

NCT ID
NCT07182682
Phase
PHASE3
Sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • sunvozertinib
  • Matching Placebo
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses.
  • Aged at least 18 years old at the time of ICF signature.
  • Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (participants with tumor histology indicative of neuro…
  • Complete surgical resection of the primary NSCLC is mandatory. All gross lesions must be completely resected to achieve microscopically negative ma…

For full eligibility, visit ClinicalTrials.gov.

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