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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanfang Hospital, Southern Medical University
  Guandong, Guangdong, China Recruiting

Study contacts

• Study coordinator: Di Lu
• Email: david_lu1989@163.com
• Phone: 020-62787240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.