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

Immunotherapy Clinical Trial

— PANORAMA  

Official title:

Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825443
• Other study ID #: NFEC-2023-031
• Status: Recruiting
• Phase: Phase 2
• Start date: April 10, 2023
• Est. completion date: April 1, 2029

Study information

• Verified date: April 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Di Lu
• Phone: 020-62787240
• Email: david_lu1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chemotherapy
• Immunotherapy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guandong	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Jiangsu Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-years disease free survival (2y-DFS)	DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.	Up to approximately 2 years
Secondary	Three-years disease free survival (3y-DFS)	According to the K-M curve, the proportion of disease-free progression in 3 years	Up to approximately 3 years
Secondary	Five-years disease free survival (5y-DFS)	According to the K-M curve, the proportion of disease-free progression in 5 years	Up to approximately 5 years
Secondary	Disease free survival (DFS)	DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.	Up to approximately 2 years
Secondary	Overall survival (OS)	Defined as the time from randomization to death from any cause.	Up to approximately 5 years
Secondary	Two-years overall survival(2y-OS)	According to the K-M curve, the proportion of OS in 2 years	Up to approximately 2 years
Secondary	Three-years overall survival(3y-OS)	According to the K-M curve, the proportion of OS in 3 years	Up to approximately 3 years
Secondary	Five-years overall survival(5y-OS)	According to the K-M curve, the proportion of OS in 5 years	Up to approximately 5 years
Secondary	Treatment-related adverse events(TRAE)	The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0	Up to approximately 1 year