Last updated: April 25, 2024
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Not Recruiting
Phase
2
Condition
N/ATreatment
Albumin Paclitaxel
Carboplatin
Pemetrexed
Clinical Study ID
NCT06391008
SBRT-AK112-C
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient voluntarily joined this study and signed an informed consent form;
- ≥ 18 years old, both male and female are eligible;
- Pathologically confirmed stage II-III NSCLC (AJCC 8th)
- NSCLC confirmed by histology or cytology; No known EGFR/ALK gene mutations
- ECOG score: 0-1;
- Expected survival time ≥ 12 weeks;
- The functions of important organs meet the following requirements: Absolute neutrophil count ≥ 1.5 × 10 ^ 9/L; Absolute lymphocyte count ≥ 0.8 × 10 ^ 9/L; Platelets ≥ 80 × 10 ^ 9/L; Hemoglobin ≥ 90g/L; Bilirubin ≤ 1.5 × ULN (within 7days before the first medication); ALT and AST ≤ 1.5 × ULN (within 7 days before thefirst medication); Serum creatinine ≤ 1.5 × ULN;
- Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should beexamined simultaneously, and if FT3 and FT4 levels are normal, they can be included inthe study);
- Non surgical sterilization or female patients of childbearing age are required to usea medically recognized contraceptive measure (such as an intrauterine device,contraceptive pill, or condom) during the study treatment period and within 3 monthsafter the end of the study treatment period; Non surgically sterilized female patientsof childbearing age must have a negative serum or urine HCG test within 72 hours priorto enrollment in the study; And it must be non lactation period; For male patientswhose partners are women of childbearing age, effective methods of contraceptionshould be used during the trial period and within 3 months after the last treatmentmedication.
- Agree to provide blood samples and histological specimens. -
Exclusion
Exclusion Criteria:
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis,enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism;the patient has vitiligo; asthma that has completely relieved in childhood and doesnot require any intervention in adulthood can be included; asthma that requiresmedical intervention with bronchodilators cannot be included);
- The patient is currently using immunosuppressive agents or systemic hormone therapy toachieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutichormones), and continues to use them within 2 weeks prior to enrollment;
- Has experienced severe allergic reactions to other monoclonal antibodies;
- Suffering from hypertension and unable to achieve good control throughantihypertensive drug treatment (systolic blood pressure ≥ 140mmHg or diastolic bloodpressure ≥ 90mmHg);
- There are clinical symptoms or diseases of the heart that cannot be well controlled,such as: NYHA grade 2 or above heart failure; Unstable angina pectoris; Have experiencedmyocardial infarction within one year; Clinically significant supraventricular orventricular arrhythmias require treatment or intervention; QTc>450ms (male); QTc>470ms (female);
- Abnormal coagulation function (INR>2.0, PT>16s), with a tendency to bleed orundergoing thrombolysis or anticoagulation treatment, allowing prophylactic use oflow-dose aspirin and low molecular weight heparin;
- Received previous anti-tumor immunotherapy, chemotherapy, and anti-tumor vaccinetreatment (excluding adjuvant chemotherapy, if receiving adjuvant chemotherapy,disease recurrence or metastasis occurs more than 6 months after the lastchemotherapy).
- The patient has active infection, unexplained fever ≥ 38.5 ° C within 7 days beforemedication, or baseline white blood cell count>15 × 109/L; Individuals with purulentand chronic infections, and wounds that persist and do not heal;
- Patients with bone metastases who have received palliative radiotherapy within the 4weeks prior to participating in this study have a bone marrow area greater than 5%;
- The patient has previously received anti PD-1, anti PD-L1, and anti PD-L2 treatments;
- Individuals who are known to be allergic to the components of recombinant humanizedanti-PD-1 monoclonal antibody drugs and vaccines;
- Pregnant or lactating women, or female patients who have fertility but have not takencontraceptive measures;
- Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficialbladder cancer cancer, cervical carcinoma in situ or breast cancer) in the past 5years;
- Patients participating in other clinical trials simultaneously
Study Design
Total Participants: 44
Treatment Group(s): 5
Primary Treatment: Albumin Paclitaxel
Phase: 2
Study Start date:
April 30, 2024
Estimated Completion Date:
June 30, 2025