Menu
Recruiting NCT06001151

Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative

Phase II Interventional Carcinoma, Non-Small-Cell Lung

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, Pemetrexed, Carboplatin.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 75 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

Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative：A Multi-center, Single-arm, Phase II Study

Overview

This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.

Detailed description

This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy. The primary endpoint is 12-month progression-free-survival (PFS) rate assessed by investigators. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), progression free survival (PFS), overall survival (OS), and safety.

Interventions

  • Drug Cadonilimab
    Patients receive cadonilimab (10mg/kg) every 3 weeks.
  • Drug Pemetrexed
    Patients receive pemetrexed (500mg/m2) every 3 weeks.
  • Drug Carboplatin
    Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.

Primary outcome measures

  • 12-month progression-free-survival (PFS) rate [Time frame: At 12 months]
Secondary outcome measures (7)
  • objective response rate (ORR) [Time frame: about 24 months]
  • duration of response (DOR) [Time frame: about 24 months]
  • disease control rate (DCR) [Time frame: about 24 months]
  • time to response (TTR) [Time frame: about 24 months]
  • progression free survival (PFS) [Time frame: about 24 months]
  • overall survival (OS) [Time frame: about 24 months]
  • incidence, type and severity of adverse events [Time frame: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)]

Eligibility criteria

Inclusion criteria

  • Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
  • PD-L1 TPS<1%
  • Life expectancy more than 3 months
  • Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
  • Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
  • ECOG score 0-1
  • Patients must have at least one measurable lesion according to RECIST 1.1
  • Has adequate organ function
  • Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
  • Voluntarily sign a written informed consent form

Exclusion criteria

  • Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
  • With active central nervous system (CNS) metastases confirmed by CT or MRI
  • With other malignancy within 3 years before enrollment
  • With severe infections within 4 weeks of the first dose of study treatment
  • Women who are pregnant or lactating
  • History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
  • History of myocarditis, cardiomyopathy, and malignant arrhythmia
  • Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
  • Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
  • Active autoimmune diseases that require systematic treatment within 2 years before enrollment
  • History of Human Immunodeficiency Virus (HIV)
  • With active hepatitis B infection
  • With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Qian Chu — Wuhan

Identifiers

NCT: NCT06001151 · S019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗