NCT06001151Active, not recruitingPhase 2
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 · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- First submitted
- 12 Aug 2023
- Start date
- 7 Aug 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Qian Chu
- Diseases
- Lung cancer
- NCT number
- NCT06001151
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 49
- From 7 Aug 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
- With other malignancy within 3 years before enrollment
- With severe infections within 4 weeks of the first dose of study treatment
- 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
Other
- With active central nervous system (CNS) metastases confirmed by CT or MRI
- Women who are pregnant or lactating
- With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qian Chu Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.