Open Actively Recruiting

Phase 3 Clinical Study of AK112 for NSCLC Patients

About

Brief 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)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

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Study Stats
Protocol No.
23-000741
Category
Lung Cancer
Contact
Angela Lool
Location
  • UCLA Alhambra
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA Playa Marina
  • UCLA Porter Ranch
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05184712
For detailed technical eligibility, visit ClinicalTrials.gov.