Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

An Open-label, Single-center, Phase II Study of Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05784974
• Other study ID #: 23K004-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: May 1, 2028

Study information

• Verified date: March 2023
• Source: The First Hospital of Jilin University
• Contact: Kewei Ma
• Phone: 0431-88782179
• Email: makw[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Cadonilimab
15 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After surgery (approximately 7 weeks)
Secondary	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	After surgery (approximately 7 weeks)
Secondary	Complete (R0) Resection Rate	defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.	After surgery (approximately 7 weeks)
Secondary	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.	At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)
Secondary	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.	Up to approximately 5 years
Secondary	Adverse Events (AEs)		From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment