NCT06467500 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 With Negative Driver Genes and Failed Immunotherapy
| NCT ID | NCT06467500 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xin-Hua Xu |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-03-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06467500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06467500 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06467500 currently recruiting?
Yes, NCT06467500 is actively recruiting participants. Contact the research team at 2732774352@qq.com for enrollment information.
Where is the NCT06467500 trial being conducted?
This trial is being conducted at Yichang, China.
Who is sponsoring the NCT06467500 clinical trial?
NCT06467500 is sponsored by Xin-Hua Xu. The trial plans to enroll 48 participants.
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