AK112-102
10 evidence topics · 2 sources
Objective
Clinical pharmacology objectives
Location and study date
Study design
Eligibility criteria
Disease population
Treatment
Study outcomes
Rationale for using treatment-emergent adverse events as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Planned and treated participants
| Quantity | Quoted count |
|---|---|
| Planned enrollment | “Fifty-four” |
| Treated participants | “59” |
Description of analysis sets
Statistical approach
Results
Participant disposition
Screened participants
Baseline characteristics
Representation of non-small-cell lung cancer
| Baseline characteristic | Quoted count and percentage |
|---|---|
| Participants with non-small-cell lung cancer, n (%) | “1 (1.7)” |
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Maximum tolerated dose finding
Study limitations
Summary
Only 1 of 59 participants, 1.7%, had NSCLC. These descriptive safety and pharmacology findings cannot establish efficacy for EGFR-mutated NSCLC. Unlike the Australian phase 1a study, this study did not reach a maximum tolerated dose; the results should not be merged into a single universal maximum-dose conclusion.