Phase III Study of AK112 for NSCLC Patients
Public ClinicalTrials.gov record NCT06396065. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT06396065
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2023 (Actual)
- Primary completion
- Apr 12, 2025 (Actual)
- Completion
- Dec 31, 2026 (Estimated)
- Last update posted
- Jul 28, 2026
2023 – 2026
United States locations
- U.S. sites
- 43
- U.S. states
- 17
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CBCC Global Research | Bakersfield | California | 93309 | — |
| UC San Diego | La Jolla | California | 92093 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | — |
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles | California | 90095 | — |
| Palo Alto Medical Foundation Research Institute | Mountain View | California | 94040 | — |
| Providence St. Joseph | Orange | California | 92868 | — |
| UC Irvine | Orange | California | 92868 | — |
| Sutter Cancer center | Sacramento | California | 95816 | — |
| UC DAVIS Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Providence Medical Foundation | Santa Rosa | California | 95403 | — |
| Presbyterian Intercommunity Hospital | Whittier | California | 90602 | — |
| Rocky Mountain Cancer Center | Lone Tree | Colorado | 80124 | — |
| The Oncology Institute of Hope & Innovation | Fort Lauderdale | Florida | 33308 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Florida Cancer Associates - Ocala Oncology | Ocala | Florida | 34474 | — |
| BRCR Global | Plantation | Florida | 33322 | — |
| Florida Cancer Specialists - North | St. Petersburg | Florida | 33705 | — |
| BRCR Global | Tamarac | Florida | 33321 | — |
| Florida Cancer Specialists -East | West Palm Beach | Florida | 33401 | — |
| Hematology/Oncology Clinic - SCRI | Baton Rouge | Louisiana | 70809 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| American Oncology Partners | Bethesda | Maryland | 20817 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| HealthPartners Cancer Research Center | Saint Paul | Minnesota | 55101 | — |
| New York Oncology/Hematology | Clifton Park | New York | 12065 | — |
| NYU Langone Laura and Isaac Perlmutter Cancer Center | New York | New York | 10016 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58102 | — |
| Zangmeister Cancer Center | Columbus | Ohio | 43219 | — |
| Oncology Hematology Care | Fairfield | Ohio | 45014 | — |
| Williamette Valley Cancer Institute and Research | Eugene | Oregon | 97401 | — |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | — |
| Medical University South Carolina | Charleston | South Carolina | 29425 | — |
| Baptist Hospital | Memphis | Tennessee | 38120 | — |
| Texas Oncology South Austin | Austin | Texas | 78745 | — |
| Texas Oncology Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| MD Anderson University of Texas | Houston | Texas | 77030 | — |
| Texas Oncology Webster | Webster | Texas | 77598 | — |
| Virginia Cancer specialisits | Fairfax | Virginia | 22031 | — |
| Compass Oncology | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06396065, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06396065 live on ClinicalTrials.gov.