Status:
RECRUITING
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination th...
Eligibility Criteria
Inclusion
- Key
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
- Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- Have adequate organ function.
- Key
Exclusion
- Mixed NSCLC and small cell lung cancer histology.
- Patients with other active malignancies within 3 years prior to enrollment.
- Known active autoimmune diseases.
- Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- Presence of other uncontrolled serious medical conditions.
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05377658
Start Date
July 26 2022
End Date
December 31 2027
Last Update
February 21 2024
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003