Phase 3 Clinical Study of AK112 for NSCLC Patients (NCT05184712) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase 3 Clinical Study of AK112 for NSCLC Patients
China322 participantsStarted 2022-01-25
Plain-language 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 Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 to ≤ 75 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 EGFR-TKI treatment and the treatment has failed
✓. Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
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; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 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