A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Huijuan Wang, MD
18638561588@163.com
18638561588
Time Frame
Start Date: 2022-07-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 43
Treatments
Experimental: AK104+albumin-bound paclitaxel+carboplatin
Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital