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 Interventional Study
Non-Small Cell Lung Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Industry
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provide a signed and dated informed consent form (ICF) prior to any study specific procedures, sampling, and analyses. 2. Aged at least 18 years old at the time of ICF signature. 3. Complete resection (R0) of the primary tumor and histologically confirmed diagnosis of NSCLC (…
Contacts

Sherry Hu, MD, PhD

+86 2161098345

sherry.hu@dizalpharma.com

CONTACT