Status and phase
Conditions
Treatments
About
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Full description
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of Sunvozertinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation. This study includes dose escalation, dose expansion, food effect (Part A) and dose extension (Part B).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Aged at least 18 years old, be able to provide a signed and dated, written informed consent.
With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations.
(ECOG) performance status 0-1.
Predicted life expectancy ≥ 12 weeks
Patient must have measurable disease according to RECIST 1.1.
Patients with brain metastasis (BM) can be enrolled under the condition that BM is previously treated and stable, neurologically asymptomatic and does not require corticosteroid treatment.
Adequate organ system function.
Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).
Part B Dose extension:
Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory prior to the study entry.
Patients should have received at least 1 line, but no more than 3 lines of systemic therapy for metastatic/locally advanced disease.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
315 participants in 9 patient groups
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Central trial contact
Pamela Yang, M.D & Ph. D; Li Zheng, M.D & Ph. D
Data sourced from clinicaltrials.gov
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