drugset / Trial / NCT06280196
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC
RandomizedParallel-groupTriple-blindTreatment
Summary
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
Timeline
- Start
- 2024-07-19
- Primary completion
- 2025-07-30
- Completion
- 2025-07-30
Outcome
Outcome not reported
Stopped: “The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT3306 | Monoclonal antibody | 200 mg | — |
| Comparator | EU-Keytruda® | Unknown | 200 mg | — |
| Comparator | US-Keytruda® | Unknown | 200 mg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |