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

NCT05784974 | Not Yet Recruiting Phase 2

• 1 other identifier: 23K004-001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pathological Complete Response (pCR) Rate

  After surgery (approximately 7 weeks)

• Complete (R0) Resection Rate

  After surgery (approximately 7 weeks)

• Objective Response Rate (ORR)

  At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)

• Disease Free Survival (DFS)

  Up to approximately 5 years

• Adverse Events (AEs)

  From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Study Arms (1)

Cadonilimab

EXPERIMENTAL

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

Interventions

Cadonilimab DRUG

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

Cadonilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kewei Ma

CONTACT

0431-88782179; makw@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 27, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share