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Recruiting NCT06617416

A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC

Phase III Interventional NSCLC (Non-small Cell Lung Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cadonilimab (AK104), Sugemalimab.
Who it may be relevant to
Registry conditions: NSCLC (Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Consolidation Therapy of AK104 Versus Sugemalimab in Patients With Unresectable Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent or Sequential Chemoradiotherapy

Overview

This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.

Interventions

  • Drug Cadonilimab (AK104)
    AK104 ivgtt Q3W
  • Drug Sugemalimab
    1200mg Q3W

Primary outcome measures

  • Progression-free survival (PFS) assessed by INV [Time frame: 3 years]
Secondary outcome measures (3)
  • OS [Time frame: 5 years]
  • 6-month PFS rate assessed by INV [Time frame: 3 years]
  • AEs [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Subjects must sign the written informed consent form (ICF) voluntarily.
  • Age ≥18 years.
  • Histologically or cytologically confirmed unresectable locally advanced (Stage III) NSCLC.
  • Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
  • Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first dose.
  • Chemotherapy regimens should be in accordance with current clinical guidelines.
  • Consolidation chemotherapy is not allowed after radiotherapy.
  • Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
  • No disease progression after concurrent or sequential chemoradiotherapy.
  • ECOG performance status score of 0-1.
  • Expected survival of over 3 months.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • The histopathology contains any component of small cell lung cancer.
  • Currently participating in another interventional clinical study.
  • Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small molecule targeted drugs.
  • Patients with clinically significant cardio-cerebrovascular or venous thromboembolic diseases.
  • Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
  • Tumor invades important vessels or organs.
  • Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma within 4 weeks prior to the first dose.
  • Presence of interstitial lung disease that requires treatment.
  • Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
  • Experienced severe infection within 4 weeks prior to the first dose.
  • Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose.
  • Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT06617416 · AK104-309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗