Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Sunvozertinib, EGFR, EGFR uncommon mutation
Brief summary
This study is a single arm study to access the anti-tumor efficacy and safety of sunvozertinib in untreated advanced NSCLC patients with EGFR uncommon mutations.
Interventions
DRUGsunvozertinib 300mg
sunvozertinib monotherapy, 300mg QD
DRUGsunvozertinib 200mg
sunvozertinib monotherapy, 200mg QD
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old 2. histologically or cytologically confirmed non-squamous NSCLC with documented EGFR uncommon mutations from a local laoratory. at least one EGFR uncommon mutation (excluding EGFR 19del/l858r/T790m/Ex 20ins ) or compund mutations with EGFR uncommon mutations. 3. predicted life expectancy ≥ 12 weeks. 4. patient must have measurable disease according to RECIST 1.1
Exclusion criteria
1. previos systemic anti-tumor therapy 2. a history of malignant tumors within 2years 3. any severa or poorly controlled systemic disease per investigator's judgement 4. active infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR) | from first dose to last dose ,up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | from first dose to first documented disease progression assessed by investigator or death due to any cause up to 48 months ,up to 18 months |
| Duration of Response (DoR) | for subject with PR or CR defined as the time from the first dose documentd CR or PR to disease progression or death up to 18 months |
Countries
China
Contacts
Primary ContactJialei Wang
Outcome results
None listed