Phase 3 Clinical Study of AK112 for NSCLC Patients
a study on Lung Cancer Non-Small Cell Lung Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UC Irvine UCLA UCSD
- Dates
- study startedcompletion around
Description
Summary
A Randomized, Double-blind, Multi-center, Phase III Clinical Study of Ivonescimab (SMT112 or AK112) or Placebo Plus 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
Details
The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed and Carboplatin in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 470 subjects will be randomized to two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin or Placebo Plus Pemetrexed and Carboplatin(Q3W, up to 4 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab (SMT112 or AK112) Plus Pemetrexed or Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.
Keywords
Non-Squamous Non-small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Carboplatin, Pemetrexed, Ivonescimab (SMT112 or AK112) Injection
Eligibility
You can join if…
Open to people ages 18 years and up
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Life expectancy ≥3 months;
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy;
- The tumor histology, cytology or hematology confirmed the presence of EGFR activating mutations before enrollment
- Have previously received 3rd generation EGFR-TKI treatment and have progressed on or following
- Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
- Major organ function prior to treatment meets the following criteria
- Patients of childbearing potential must agree to use effective contraceptive measures
You CAN'T join if...
- Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
- There are reports confirming the existence of other driver gene mutations with known drug treatments
- Subjects who received any prior treatments targeting the mechanism of tumor immunity
- The subject has received systemic anti-tumor therapy other than EGFR-TKI
- Currently enrolled in any other clinical study
- Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose.
- Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels.
- Symptomatic central nervous system metastases
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
- There is a history of major diseases 1 year prior to the first dose.
- .Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- Received chest radiation therapy prior to the first dose
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
- Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
Locations
- UC San Diego
accepting new patients
La Jolla California 92093 United States - UCLA Jonsson Comprehensive Cancer Center
accepting new patients
Los Angeles California 90024 United States - UC Irvine
accepting new patients
Orange California 92868 United States - UC Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 95817 United States - Valkyrie Clinical Trials
accepting new patients
Los Angeles California 90067 United States - California Pacific Medical Center
accepting new patients
San Francisco California 94110 United States - University of Southern California
accepting new patients
Los Angeles California 90007 United States - Hematology-Oncology Medical Group of Orange County, Inc
accepting new patients
Orange California 92868 United States - Sutter Cancer Center
accepting new patients
Sacramento California 95816 United States - Presbyterian Intercommunity Hospital (PIH)
accepting new patients
Whittier California 90602 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Summit Therapeutics
- ID
- NCT05184712
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 470 study participants
- Last Updated