AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Recruiting
Phase 2Interventional Study
Non-small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
43 (estimated)
Sponsor
Henan Cancer Hospital · Government
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
4. Have adequate organ functio…
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
4. Have adequate organ function.
Key Exclusion Criteria:
1. Mixed NSCLC and small cell lung cancer histology.
2. Patients with other active malignancies within 3 years prior to enrollment.
3. Known active autoimmune diseases.
4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
5. Presence of other uncontrolled serious medical conditions.
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