Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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.
- interventionNames
- Drug: Cadonilimab
- Drug: Pemetrexed
- Drug: Carboplatin
Primary outcomes (1)
- measure
- 12-month progression-free-survival (PFS) rate
- timeFrame
- At 12 months
- description
- Rate of patients with complete/partial response at 12-month from enrollment
Secondary outcomes (7)
- measure
- objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available