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Trial Title:
Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients
NCT ID:
NCT05825443
Condition:
Immunotherapy
Chemotherapy
Conditions: Official terms:
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Conditions: Keywords:
Camrelizumab
Non-small Cell Lung Cancer
Adjuvant therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Four cycles of chemotherapy combine with camrelizumab, followed by maintenance with
camrelizumab until one year or the disease progressed or unacceptable toxicity
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Patients received four 21-day cycles of chemotherapy (decided by the researcher) combined
with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in
day 1, q3w), until one year or the disease progressed or unacceptable toxicity.
Arm group label:
Treatment group
Other name:
Cisplatin
Other name:
carboplatin
Other name:
pemetrexed
Other name:
paclitaxel liposome
Other name:
albumen-paclitaxel
Summary:
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung
cancer has become a new treatment recommendation, but there are still many clinical
problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore
the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients
with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the
protocol and sign the informed consent form received 4 cycles of chemotherapy combined
with camrelizumab, followed by maintenance with camrelizumab until one year or the
disease progressed or unacceptable toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form before starting the study;
2. For patients with non-small cell lung cancer who have undergone surgical resection,
the TNM stage after surgery is IIA-IIIA;
3. Patients cannot receive targeted adjuvant therapy;
4. 18-80 years old;
5. The patient can recover within 3-8 weeks after the operation, and receive
postoperative adjuvant treatment;
6. The ECOG PS score is 0 or 1;
7. Have not received any chemotherapy for non-small cell lung cancer before enrollment;
8. Within 7 days before enrollment, the laboratory inspection must meet all the
following requirements:
- Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L,
hemoglobin ≥ 9g/dL;
- Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
- Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
9. Female patients must meet: menopause or have undergone surgical sterilization. Women
with fertility must take effective contraceptive measures. Do not breastfeed.
10. Male patients must agree to use appropriate contraceptive measures.
Exclusion Criteria:
1. Known or suspected to be allergic to the drug or any component of the drug related
to the test;
2. Patients who can receive targeted treatment;
3. Other malignant tumors in five years before enrollment, excluding the cured cervical
carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors
that were cured only after surgical treatment;
4. Myocardial infarction, unstable angina pectoris and grade II congestive heart
failure in six months before enrollment; New angina pectoris occurred within 3
months; Ventricular arrhythmia requiring medication;
5. Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic
blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
6. History of HIV infection, active period of HCV infection, active period of HBV
infection (HBV-DNA>1000 copies/ml);
7. The researcher judged that there was a risk of bleeding;
8. Active severe clinical infection (≥ grade 3 CTCAE V5.0);
9. Epilepsy patients who need medication;
10. Allogeneic organ transplantation;
11. Patients who need kidney dialysis;
12. Thrombotic or embolic venous or arterial events occurred within six months before
enrollment;
13. Serious uncured wounds, ulcers or fractures;
14. Interstitial pneumonia;
15. Any malabsorption disease;
16. Any disease that is unstable or may endanger the patient's safety;
17. Drug abuse, medical, psychological or social diseases;
18. Participate in other clinical studies within 3 months before enrollment;
19. During pregnancy or lactation;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guandong
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Di Lu, MD, PhD
Phone:
86+13268379321
Email:
david_lu189@163.com
Start date:
April 10, 2023
Completion date:
April 1, 2029
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05825443
