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

Phase 2

Not yet recruiting

• Conditions: Lung Cancer
• Interventions: Drug: Cadonilimab

• Registration Number: NCT05784974
• Lead Sponsor: The First Hospital of Jilin University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Study Start: 2023-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab	Cadonilimab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Complete (R0) Resection Rate	After surgery (approximately 7 weeks)	defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
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
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.