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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQian Chu

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cadonilimab
  • Pemetrexed
  • Carboplatin

Treatment groups

49 Participants
are divided into 1 treatment group

Sponsors and collaborators

Qian Chu

Lead sponsor

Tongji Hospital

Sponsor institution

Akeso Pharmaceuticals, Inc.

Collaborator