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

Jilin University

Status and phase: Not yet enrolling; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Cadonilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05784974

23K004-001

Details and patient eligibility

About

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.

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Cadonilimab

Experimental group

Description:

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.

Treatment:

Drug: Cadonilimab