AK112-201
10 evidence topics · 2 sources
Objective
Location and study date
Study design
Phase II study: design
| Evidence element | Direct quotation |
|---|---|
| Design | “open-label, multicenter, phase II” |
Eligibility criteria
Phase II study: EGFR-mutated cohort
| Evidence element | Direct quotation |
|---|---|
| Population | “The participants in cohort 2 had advanced NSCLC with EGFR-sensitive mutations” |
Treatment
Cohort 2 induction treatment
Study outcomes
Rationale for using objective response rate as a primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Participants in the EGFR-mutated cohort
Description of analysis sets
Results
Participant disposition
Baseline characteristics
Efficacy results
Phase II study: EGFR-mutated cohort efficacy
| Evidence element | Direct quotation |
|---|---|
| Objective response rate, cohort 2 | “68.4% (13/19) [95% CI, 43.4-87.4]” |
| Median progression-free survival, cohort 2, months | “8.5 [95% CI, 5.5-NE]” |
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study-wide severe white blood cell count decrease
Study limitations
Summary
The EGFR-mutated cohort contained 19 participants in an open-label study without a concurrent randomized comparator. Its ORR confidence interval was 43.4% to 87.4%, and the PFS upper confidence limit was not estimable. These results do not establish a comparative survival benefit. The study-wide safety percentage is not an EGFR-cohort-specific estimate.