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

NCT06467500 | Recruiting Phase 2

• 1 other identifier: CTGU010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  The objective response rate (ORR) refers to the proportion of patients whose tumor shrinks by a certain percentage (generally 30%) and maintains this reduction for a certain period of time (generally 4 weeks).

  approximately 24 months

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  approximately 24 months

• Duration of Response (DoR)

  approximately 24 months

• Progression-free survival (PFS)

  approximately 24 months

• Overall Survival (OS)

  approximately 24 months

• Adverse event (AE)

  approximately 24 months

Study Arms (1)

Bispecific antibody plus Chemotherapy

EXPERIMENTAL

Drug: Cadonilimab (AK104)

Interventions

Cadonilimab (AK104) DRUG

Subjects participated in a study where they received cadonilimab intravenously at 6mg/kg every two weeks, prepared in 100mL of normal saline (0.9% NaCl), with a final concentration range of 0.2-5.0mg/mL. The infusion solution must be used within 4 hours of preparation. Treatment continued until disease progression (PD), unacceptable toxicity, or 24 months, whichever came first. Patients who investigators deemed could still benefit from cadonilimab post-PD were allowed continued treatment. Chemotherapy regimens were selected by investigators based on prior medication use, including gemcitabine, pemetrexed, docetaxel, albumin-bound paclitaxel, or vinorelbine as second- or third-line therapy

Bispecific antibody plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in clinical research; Fully understand and be informed of this study and sign the informed consent form;
• Age ≥ 18 and ≤ 75, male or female;
• ECOG physical performance score of 0-2;
• Patients with histologically confirmed squamous or non-squamous advanced non- small cell lung cancer (according to AJCC, 8th edition);
• Patients who tested negative for driver genes after genetic testing;
• Patients who have undergone previous systemic therapy and failed anti-PD-1/PD- L1 immunotherapy;
• Presence of at least one measurable lesion as defined by Recist criteria 1.1;
• 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;
• 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.

You may not qualify if:

• ECOG physical performance score \> 2;
• Previous treatment with bispecific antibodies;
• Participation in other clinical trials within 30 days prior to screening;
• Tumor metastasis to the brain and/or leptomeninges;
• 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);
• Accompanied by other serious diseases, including but not limited to:
• 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);
• Severe active infection;
• 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);
• Mental illness affecting informed consent and/or protocol compliance.
• Allergy to the drugs used in this protocol or their ingredients;
• 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;
• Investigators consider it inappropriate to participate in this study;
• Unwilling to participate in this study or unable to sign the informed consent form.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, 443002, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xinhua Xu, Master

CONTACT

+8613986747496; 2732774352@qq.com

Xinhua Xinhua, Master

CONTACT

+8613986747496; 2732774352@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)