AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104, Albumin-Bound Paclitaxel, Carboplatin.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Overview
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.
Interventions
- Drug AK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. - Drug Albumin-Bound Paclitaxel
260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle. - Drug Carboplatin
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Primary outcome measures
- Pathological Complete Response (pCR) Rate [Time frame: At time of surgery]
Secondary outcome measures (6)
- Major Pathological Response (MPR) Rate [Time frame: At time of surgery]
- Incidence of Surgical Complications [Time frame: Up to approximately 30 days following surgery]
- Complete (R0) Resection Rate [Time frame: After surgery (approximately 7 weeks)]
- Objective Response Rate (ORR) [Time frame: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)]
- Event Free Survival (EFS) [Time frame: Up to approximately 5 years]
- Adverse Events (AEs) [Time frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Henan Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT05377658 · AK104-IIT-005