Status:
ACTIVE_NOT_RECRUITING
Phase 3 Clinical Study of AK112 for NSCLC Patients
Lead Sponsor:
Akeso
Conditions:
Non-Squamous Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare AK112 Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed and Carboplatin in Patients with Locally Advanc...
Eligibility Criteria
Inclusion
- 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
- Major organ function prior to treatment meets the following criteria
- Patients of childbearing potential must agree to use effective contraceptive measures
Exclusion
- 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
- 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).
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2025
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT05184712
Start Date
January 25 2022
End Date
November 2 2025
Last Update
June 28 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000