AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Recruiting · NCT05377658 · Interventional (participants receive a specific treatment) · Lead sponsor: Henan Cancer Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Henan Cancer Hospital - Zhengzhou, Henan, China