Lung Cancer
Conditions
Brief summary
Cadonilimab, 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 Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.
Interventions
DRUGCadonilimab
15 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Sponsors
The First Hospital of Jilin University
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: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function. Key
Exclusion criteria
Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological Response (MPR) Rate | After surgery (approximately 7 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate | After surgery (approximately 7 weeks) | 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 |
| Complete (R0) Resection Rate | After surgery (approximately 7 weeks) | defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy. |
| Objective Response Rate (ORR) | At the end of 2 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. |
| Disease Free Survival (DFS) | 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 | — |
Contacts
Primary ContactKewei Ma
Outcome results
None listed