Non-small Cell Lung Cancer
Conditions
Keywords
neoadjuvant and adjuvant therapy, bispecific antibody
Brief 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.
Interventions
DRUGAK104
10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
DRUGAlbumin-Bound Paclitaxel
260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.
DRUGCarboplatin
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate | At time of surgery | defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Complications | Up to approximately 30 days following surgery | defined as ≥ grade 3 or severe intraoperative and perioperative complications. |
| Complete (R0) Resection Rate | After surgery (approximately 7 weeks) | defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy. |
| Major Pathological Response (MPR) Rate | At time of surgery | defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. |
| Event Free Survival (EFS) | Up to approximately 5 years | defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first. |
| Adverse Events (AEs) | From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment | — |
| Objective Response Rate (ORR) | At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days) | defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1. |
Countries
China
Contacts
Primary ContactHuijuan Wang, MD
Outcome results
None listed