Clinical Trial: NCT06396065
Phase III Study of AK112 for NSCLC Patients
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Summit Therapeutics |
| Information Provided By: | Summit Therapeutics |
| Last Update Posted: | 2026-07-28 |
Study Overview
Brief Summary
A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)
Official Title
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Conditions
Non-Squamous Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: AK112 Injection
- Drug: Placebo Injection
Other Study ID Numbers
- AK112-301 (HARMONi)
Start Date (Actual)
2023-05-04
Primary Completion Date (Actual)
2025-04-12
Study Completion Date (Estimated)
2026-12-31
Enrollment (Actual)
420
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Summit Therapeutics |
| Information Provided By: | Summit Therapeutics |
| Last Update Posted: | 2026-07-28 |
Study Overview
Brief Summary
A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)
Official Title
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Conditions
Non-Squamous Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: AK112 Injection
- Drug: Placebo Injection
Other Study ID Numbers
- AK112-301 (HARMONi)
Start Date (Actual)
2023-05-04
Primary Completion Date (Actual)
2025-04-12
Study Completion Date (Estimated)
2026-12-31
Enrollment (Actual)
420
Study Type
Interventional
Phase
Phase 3