Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06424821

Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-05-22

54

Participants Needed

2

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.

CONDITIONS

Official Title

Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent must be obtained before any trial procedures
  • Age between 18 and 80 years
  • Expected survival longer than 3 months
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Wild-type EGFR and ALK genes
  • Diagnosed with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC not eligible for curative surgery or definitive radiotherapy/chemotherapy
  • PD-L1 expression in tumor tissue with Tumor Proportion Score (TPS) less than 1%
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • No prior systemic anti-tumor treatment for advanced/metastatic disease; prior platinum-based adjuvant/neoadjuvant chemotherapy or radiotherapy allowed if progression occurred more than 6 months after last treatment
  • Adequate blood counts: absolute neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L without recent transfusion
  • Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN (or ≤ 5 times ULN if liver metastases present)
  • Adequate kidney function: serum creatinine ≤ 1.5 times ULN
  • Adequate coagulation: INR or prothrombin time ≤ 1.5 times ULN; if on anticoagulants, values within planned range
  • Women of childbearing potential must have a negative pregnancy test within 7 days before treatment and use reliable contraception during and for 30 days after the trial; male participants must use condoms during and for 30 days after the trial
  • Willingness to comply with regular follow-up and trial requirements
Not Eligible

You will not qualify if you...

  • Currently participating in other interventional clinical research
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor-targeting drugs
  • Use of traditional Chinese medicine or immunomodulatory anti-tumor drugs within 2 weeks before first dose
  • Known allergy to Cadonilimab or its ingredients
  • Active bleeding in the lungs, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring intervention
  • Uncontrolled pleural effusion or ascites requiring drainage
  • Tumor compressing important organs with symptoms or invading major blood vessels or heart
  • Recent severe cardiovascular events or serious thrombotic events within 3 to 6 months prior to enrollment
  • History of autoimmune diseases except stable hypothyroidism or controlled type 1 diabetes
  • Use of systemic corticosteroids or immunosuppressive agents within 2 weeks before randomization
  • Active systemic infections including tuberculosis, hepatitis B or C, or HIV
  • Mental illness or substance abuse affecting compliance
  • Any condition or abnormality that may interfere with trial participation or results as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Not Yet Recruiting

2

NINGBO No.2 Hospital

Ningbo, Zhejiang, China, 315016

Actively Recruiting

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Research Team

L

Li Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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