Status:
NOT_YET_RECRUITING
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
Lead Sponsor:
Akeso
Conditions:
Locally Advanced or Metastatic NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Loca...
Eligibility Criteria
Inclusion
- The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
- Aged ≥18 years when the subject signed the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
- No prior systemic therapy for advanced or metastatic NSCLC was received.
- PD-L1 TPS \< 1%.
- No EGFR sensitive mutations or ALK gene translocation alterations.
Exclusion
- Histologically confirmed small cell lung cancer (SCLC).
- NSCLC with driver gene mutations for approved targeted drug indications.
- Active central nervous system (CNS) metastases were present.
- Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
- Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
- Pregnant or lactating women.
- Clinically significant cardiovascular or cerebrovascular disease.
- Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
- Known active pulmonary tuberculosis.
- Patients with active hepatitis B or active hepatitis C.
- Known medical history of immunodeficiency or positive HIV test.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2026
Estimated Enrollment :
642 Patients enrolled
Trial Details
Trial ID
NCT05990127
Start Date
November 14 2023
End Date
November 28 2026
Last Update
August 14 2023
Active Locations (62)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233099
2
Anhui provincial hospital
Hefei, Anhui, China, 230001
3
Anhui provincial cancer hospital
Hefei, Anhui, China, 230088
4
The first affiliated hospital of wannan medical college
Wuhu, Anhui, China, 241001