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Recruiting NCT05825443

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

Phase II Interventional Immunotherapy Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab.
Who it may be relevant to
Registry conditions: Immunotherapy, Chemotherapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Two-years disease free survival (2y-DFS) [Time frame: Up to approximately 2 years]
Secondary outcome measures (8)
  • Three-years disease free survival (3y-DFS) [Time frame: Up to approximately 3 years]
  • Five-years disease free survival (5y-DFS) [Time frame: Up to approximately 5 years]
  • Disease free survival (DFS） [Time frame: Up to approximately 2 years]
  • Overall survival (OS) [Time frame: Up to approximately 5 years]
  • Two-years overall survival（2y-OS) [Time frame: Up to approximately 2 years]
  • Three-years overall survival（3y-OS) [Time frame: Up to approximately 3 years]
  • Five-years overall survival（5y-OS) [Time frame: Up to approximately 5 years]
  • Treatment-related adverse events（TRAE） [Time frame: Up to approximately 1 year]

Eligibility criteria

Inclusion criteria

  • Sign the informed consent form before starting the study;
  • For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
  • Patients cannot receive targeted adjuvant therapy;
  • 18-80 years old;
  • The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
  • The ECOG PS score is 0 or 1;
  • Have not received any chemotherapy for non-small cell lung cancer before enrollment;
  • 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;
  • Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
  • Male patients must agree to use appropriate contraceptive measures.

Exclusion criteria

  • Known or suspected to be allergic to the drug or any component of the drug related to the test;
  • Patients who can receive targeted treatment;
  • 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;
  • 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;
  • Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
  • History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA>1000 copies/ml);
  • The researcher judged that there was a risk of bleeding;
  • Active severe clinical infection (≥ grade 3 CTCAE V5.0);
  • Epilepsy patients who need medication;
  • Allogeneic organ transplantation;
  • Patients who need kidney dialysis;
  • Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
  • Serious uncured wounds, ulcers or fractures;
  • Interstitial pneumonia;
  • Any malabsorption disease;
  • Any disease that is unstable or may endanger the patient's safety;
  • Drug abuse, medical, psychological or social diseases;
  • Participate in other clinical studies within 3 months before enrollment;
  • During pregnancy or lactation;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guandong

Identifiers

NCT: NCT05825443 · NFEC-2023-031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗