Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients

NCT ID: NCT05825443

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2029-04-01

Brief 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.

Conditions

Immunotherapy; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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. The chemotherapy regimen is decided by the researcher.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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.

Interventions

Camrelizumab

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.

Intervention Type: DRUG

Other Intervention Names

Cisplatin; carboplatin; pemetrexed; paclitaxel liposome; albumen-paclitaxel

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guandong, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Di Lu

Role: CONTACT

david_lu1989@163.com

020-62787240

Facility Contacts

Di Lu, MD, PhD

Role: primary

david_lu189@163.com

86+13268379321

Other Identifiers

NFEC-2023-031

Identifier Type: -

Identifier Source: org_study_id