Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06396065 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of AK112 for NSCLC Patients
A Phase 3 study of Non-squamous Non-small Cell Lung Cancer, sponsored by Summit Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT06396065: Active Phase 3 study of Non-squamous Non-small Cell Lung Cancer, sponsored by Summit Therapeutics.
NCT06396065 is a Phase 3 study of Non-squamous Non-small Cell Lung Cancer that is active but no longer recruiting, run by Summit Therapeutics. The registered enrollment target is 420 participants, above the 351-participant average among 9 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06396065, a Phase 3 study of Non-squamous Non-small Cell Lung Cancer, is active but no longer recruiting, sponsored by Summit Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
Progression-free survival (PFS) assessed by IRC per RECIST v1.1 in the ITT population.
Conditions Studied
Interventions
- DRUG Placebo Injection
- DRUG AK112 Injection
Study Locations (20)
California
- CBCC Global Research - Bakersfield
- UC San Diego - La Jolla
- University of Southern California - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles
- Palo Alto Medical Foundation Research Institute - Mountain View
- Providence St. Joseph - Orange
- UC Irvine - Orange
- Sutter Cancer center - Sacramento
- UC DAVIS Comprehensive Cancer Center - Sacramento
- Sharp Memorial Hospital - San Diego
- California Pacific Medical Center - San Francisco
- Providence Medical Foundation - Santa Rosa
- Presbyterian Intercommunity Hospital - Whittier
Florida
- The Oncology Institute of Hope & Innovation - Fort Lauderdale
- University of Miami - Miami
- Florida Cancer Associates - Ocala Oncology - Ocala
- BRCR Global - Plantation
- Florida Cancer Specialists - North - St. Petersburg
Colorado
- Rocky Mountain Cancer Center - Lone Tree
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-05-04 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT06396065 still lists
NCT06396065 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 351-participant average among 9 other Non-squamous Non-small Cell Lung Cancer trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Non-squamous Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo Injection is the first listed.
NCT06396065 names 20 study sites across 3 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT06396065 about?
NCT06396065 is a clinical study titled "Phase III Study of AK112 for NSCLC Patients". 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 Kina...
What is the current status of trial NCT06396065?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2023-05-04. Estimated completion is 2026-12-31.
What conditions does trial NCT06396065 study?
This clinical trial studies the following conditions: Non-squamous Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT06396065?
The interventions under investigation include: Placebo Injection (DRUG), AK112 Injection (DRUG).
Who is sponsoring clinical trial NCT06396065?
This trial is sponsored by Summit Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06396065 being conducted?
This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-squamous Non-small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06396065's enrollment target sits among peer trials
420 5th of 9 higher than 5 of 9 other Non-squamous Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-squamous Non-small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
RECRUITING · Phase 3
-
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
COMPLETED · Phase 3
-
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
COMPLETED · Phase 3
-
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI