Combining chemotherapy with camrelizumab for non-small cell lung cancer patients after surgery

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

This study is testing if combining chemotherapy with the immunotherapy drug camrelizumab helps patients with stage IIA-IIIA non-small cell lung cancer feel better after their surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy, camrelizumab, immunotherapy
• Locations: 1 site (Guandong, Guangdong)
• Trial ID: NCT05825443 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of adjuvant chemotherapy combined with the immunotherapy drug camrelizumab in patients with stage IIA-IIIA non-small cell lung cancer who have undergone surgical resection. Participants will receive four cycles of chemotherapy followed by maintenance therapy with camrelizumab for up to one year, unless the disease progresses or they experience unacceptable side effects. The goal is to address clinical challenges in postoperative adjuvant immunotherapy for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with stage IIA-IIIA non-small cell lung cancer who have undergone surgery and meet specific health criteria.

Not a fit: Patients who have received prior chemotherapy for non-small cell lung cancer or those who cannot undergo adjuvant therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with non-small cell lung cancer after surgery.

How similar studies have performed: Other studies have shown promise in combining chemotherapy with immunotherapy for lung cancer, suggesting potential for success in this approach.

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;

Where this trial is running

Guandong, Guangdong

• Nanfang Hospital, Southern Medical University — Guandong, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Di Lu

Conditions Immunotherapy; Chemotherapy; Camrelizumab; Non-small Cell Lung Cancer; Adjuvant therapy