Combination of Cadonilimab and chemotherapy for treating non-squamous lung cancer
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
This study is testing if a new combination of cadonilimab and chemotherapy can help people with advanced non-squamous lung cancer who are PD-L1 negative live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, Cadonilimab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06001151 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of cadonilimab, a PD-1/CTLA-4 bi-specific antibody, combined with chemotherapy in patients with advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) who are PD-L1 negative. Participants will receive cadonilimab along with pemetrexed and carboplatin for four cycles, followed by maintenance therapy with cadonilimab and pemetrexed. The primary goal is to assess the 12-month progression-free survival rate, while secondary endpoints include overall survival and safety assessments. This is a single-arm, multi-center trial designed to provide insights into a new treatment approach for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced or metastatic non-squamous NSCLC who have a PD-L1 tumor proportion score of less than 1% and meet specific eligibility criteria.
Not a fit: Patients with small cell lung cancer or squamous non-small cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with PD-L1 negative non-squamous NSCLC.
How similar studies have performed: Other studies have shown promise with similar combination therapies, but this specific approach is novel for PD-L1 negative patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan, Hubei
- Qian Chu — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Qian Chu — Tongji Hospital
- Study coordinator: Qian Chu
- Email: qianchu@tjh.tjmu.edu.cn
- Phone: 13212760751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.