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

Phase 2Not Yet RecruitingNCT05784974

The First Hospital of Jilin University37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

CadonilimabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Central Contacts

Kewei Ma

CONTACT

0431-88782179 makw@jlu.edu.cn

Data from ClinicalTrials.gov

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