A Phase 2 interventional study of Cadonilimab in Lung Cancer, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by The First Hospital of Jilin University · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 37 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Participants receive two cycles of Cadonilimab as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- adjuvant Cadonilimab for 6 months.
Drug: Cadonilimab
15 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Major Pathological Response (MPR) Rate
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
Time frame: After surgery (approximately 7 weeks)
Pathological Complete Response (pCR) Rate
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
Time frame: After surgery (approximately 7 weeks)
Complete (R0) Resection Rate
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Time frame: After surgery (approximately 7 weeks)
Objective Response Rate (ORR)
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Time frame: At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)
Disease Free Survival (DFS)
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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University