Cadonilimab(AK104) Plus Concurrent Chemoradiotherapy in Patients With Locally Advanced, Unresectable, Stage III NSCLC

NCT06448910 | Active Not Recruiting Phase 2

• 1 other identifier: Lung-AK104
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single arm, phase II clinical trial is to evaluate the efficacy and safety of cadonilimab (AK104) as induction and consolidation therapy in locally advanced/unresectable non-small cell lung cancer (NSCLC) patients treated with concurrent chemoradiotherapy. Participants will receive 2 cycles of induction therapy with cadonilimab combined with carboplatin/cisplatin plus etoposide, followed by standard concurrent chemoradiotherapy (thoracic radiotherapy + carboplatin/cisplatin plus etoposide regimen chemotherapy), and finally consolidation therapy with cadonilimab (AK104) for 1 year.

Conditions

NSCLC; Locally Advanced Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective response rate，ORR

  According to RECISIT1.1 criteria, the proportion of patients achieving CR and PR as their best response before initial disease progression was evaluated.

  3 years

• The incidence rate of treatment-related adverse events

  The proportion of treatment-related toxicity to the total number of evaluable cases was evaluated according to CTCAE 5.0 criteria.

  3 years

Secondary Outcomes (5)

• ORR before Concurrent Chemoradiotherapy

  3 years

• disease control rate before Concurrent Chemoradiotherapy

  3 years

• Overall survival，OS

  3 years

• Progression free survival，PFS

  3 years

• 12 months PFS

  3 years

Study Arms (1)

Cadonilimab plus concurrent chemoradiotherapy

EXPERIMENTAL

Drug: Cadonilimab (AK104)

Interventions

Cadonilimab (AK104) DRUG

Participants will receive 2 cycles of induction therapy with cadonilimab combined with carboplatin/cisplatin plus etoposide, followed by standard concurrent chemoradiotherapy (thoracic radiotherapy + carboplatin/cisplatin plus etoposide), and finally consolidation therapy with cadonilimab (AK104) for 1 year.

Also known as: Concurrent Chemoradiotherapy

Cadonilimab plus concurrent chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

• Age: ≥18 years old;
• ECOG physical status: 0-1;
• The expected survival time is more than 3 months;
• Patients with locally advanced/unresectable stage IIIA-C NSCLC confirmed by histopathology or cytology based on the AJCC 8th edition staging system at initial diagnosis；
• Did not receive any anti-tumor treatment;
• No known sensitive EGFR/ALK/ROS1 mutations
• According to RECIST criteria, at least one measurable lesion must be used as the target lesion
• Good organ function ≤ 7 days before the first dose of study drug, as indicated by the following laboratory values:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥90g/L;
• INR or PT ≤1.5 x ULN;
• aPTT ≤1.5 x ULN;
• Total serum bilirubin ≤1.5 x ULN;
• AST and ALT ≤ 2.5x ULN or ≤5×ULN in patients with liver metastases;
• albumin ≥25 g/L (2.5 g/dL);
• Serum creatinine ≤1.5 times the upper limit of normal value (ULN), or serum creatinine clearance calculated by Cockcroft-Gault formula \>50 mL/min;

You may not qualify if:

• Pathological types of mixed small cell and non-small cell lung cancer;
• Patients with known EGFR/ALK/ROS1 mutations;
• Patients have received an approved systemic anticancer therapy or systemic immunomodulatory agent (including, but not limited to, interferon, interleukin-2, and tumor necrosis factor) within 4 weeks before the first dose;
• Have received a live or attenuated live vaccine within 4 weeks before enrollment or are expected to require a live or attenuated live vaccine during the study or within 5 months after the last dose of Cadonilimab (AK104);
• Patients allergic to Cadonilimab(AK104) or any of the ingredients, or the container;
• Untreated patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA≥500 IU/mL or patients with active hepatitis C:
• Patients with inactive HBsAg carriers and medically stable active HBV infection (HBV DNA\<500 IU/mL) were eligible. Only to hepatitis b core antibody (anti HBc antibody) patients who tested positive for HBV DNA testing.
• Patients who were negative for hepatitis C virus (HCV) antibodies at screening or who were positive for HCV antibodies at screening and subsequently tested negative for HCV RNA were eligible. HCV RNA testing will be performed only in patients who are positive for hepatitis C virus (HCV) antibodies.
• Note: the hepatitis b surface antigen (HBsAg) can be detected or patients with HBV DNA can be detected, should according to the guidelines for treatment. Patients receiving antiviral treatment at screening were supposed to have been on treatment for more than 2 weeks before enrollment and to have continued treatment for 6 months after discontinuation of the study drug.
• Need systemic treatment of active autoimmune disease, the researchers reckon have an impact on research and treatment of patients;
• Any condition requiring systemic treatment with a corticosteroid (prednisone or equivalent \>10 mg/ day) or other immunosuppressive agent, within 14 days before the first dose of the study drug, that was assessed by the investigator as having an impact on the study treatment;
• Severe chronic or active infection (including tuberculosis infection, etc.) requiring antimicrobial, antifungal, or antiviral systemic therapy within 14 days prior to the first dose of study drug
• Always allogeneic stem cell transplantation or organ transplantation;
• Meet the following any kind of cardiovascular risk factors of standard:
• Cardiogenic chest pain ≤28 days before the first dose of study drug, defined as moderate pain that limits instrumental exercise of daily living;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)