Combining cadonilimab with chemotherapy for advanced lung cancer patients who failed immunotherapy

A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driver Genes and Failed Immunotherapy

This study is testing if adding a new drug called cadonilimab to chemotherapy can help adults with advanced lung cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China Three Gorges University, Yichang, China (Academic / other)
• Drugs / interventions: immunotherapy, cadonilimab, chemotherapy
• Locations: 1 site (Yichang)
• Trial ID: NCT06467500 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of cadonilimab (AK104), a bispecific antibody targeting PD-1 and CTLA-4, when combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have negative driver genes and have previously failed immunotherapy. The study is designed as a single-arm, open-label Phase II trial, focusing on patients aged 18 to 75 with measurable lesions. The goal is to provide a more effective and safe treatment option for this specific patient population, which currently lacks effective therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced NSCLC, negative driver genes, and a history of failed immunotherapy.

Not a fit: Patients with positive driver genes or those who have not previously undergone immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced NSCLC who have limited treatment alternatives.

How similar studies have performed: While cadonilimab has shown promise in other cancers, this specific combination approach in NSCLC is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Voluntarily participate in clinical research; Fully understand and be informed of this study and sign the informed consent form;

1. Age ≥ 18 and ≤ 75, male or female;
2. ECOG physical performance score of 0-2;
3. Patients with histologically confirmed squamous or non-squamous advanced non- small cell lung cancer (according to AJCC, 8th edition);
4. Patients who tested negative for driver genes after genetic testing;
5. Patients who have undergone previous systemic therapy and failed anti-PD-1/PD- L1 immunotherapy;
6. Presence of at least one measurable lesion as defined by Recist criteria 1.1;
7. Liver function: Total serum bilirubin ≤ 1.5 × ULN; For subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, and for those with liver metastasis, ALT and AST ≤ 5 × ULN;
8. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 45 mL/min (using the Cockcroft/Gault formula); Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 70 × 109/L; Hemoglobin ≥ 80g/L (no blood transfusion or use of hematopoietic stimulating drugs for correction within 7 days before screening) with an expected lifespan of more than 3 months.

Exclusion Criteria:

1. ECOG physical performance score \> 2;
2. Previous treatment with bispecific antibodies;
3. Participation in other clinical trials within 30 days prior to screening;
4. Tumor metastasis to the brain and/or leptomeninges;
5. History of other malignancies (excluding cervical carcinoma in situ or skin basal cell carcinoma that has been cured, and other malignancies that have been cured for more than 5 years);
6. Accompanied by other serious diseases, including but not limited to:

   1. Difficult-to-control congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled moderate to severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg);
   2. Severe active infection;
   3. Difficult-to-control diabetes (referring to large fluctuations in blood sugar despite standard insulin therapy and frequent blood glucose monitoring, affecting the patient's life and frequently causing hypotension);
   4. Mental illness affecting informed consent and/or protocol compliance.
7. Allergy to the drugs used in this protocol or their ingredients;
8. Pregnant (confirmed by blood or urine HCG testing) or breastfeeding women, or subjects of reproductive age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last experimental treatment;
9. Investigators consider it inappropriate to participate in this study;
10. Unwilling to participate in this study or unable to sign the informed consent form.

Where this trial is running

Yichang

• Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University — Yichang, China (Recruiting)

Study contacts

• Study coordinator: Xinhua Xu, Master

Conditions Non-small Cell Lung Cancer