AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Henan Cancer Hospital
43 participants
Jul 26, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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.
Interventions
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05377658