Actively Recruiting
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
Led by Nanfang Hospital, Southern Medical University · Updated on 2023-04-25
57
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining postoperative chemotherapy with immunotherapy for patients with stage IIA to IIIA non-small cell lung cancer after surgery. This Phase II, single-arm study addresses clinical challenges in postoperative adjuvant immunotherapy and aims to improve treatment recommendations for this patient group. Participants receive four cycles of chemotherapy combined with camrelizumab, an immunotherapy drug administered at 200 mg on day 1 of each 21-day cycle. After these cycles, patients continue with maintenance therapy using camrelizumab every three weeks for up to one year, or until the disease worsens or unacceptable side effects occur. The chemotherapy regimen used is determined by the researcher. During the study, participants are monitored through laboratory tests, physical evaluations, and assessments of overall health. The main measure of success is two-year disease-free survival, with additional follow-up for survival rates and treatment-related side effects up to five years. Researchers track safety and treatment effects regularly, and participants are followed for approximately up to five years to assess long-term outcomes.
CONDITIONS
Brief Title
Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting the study
- Diagnosed with stage IIA to IIIA non-small cell lung cancer after surgical resection
- Not receiving targeted adjuvant therapy
- Aged between 18 and 80 years
- Able to recover and start postoperative adjuvant treatment within 3 to 8 weeks after surgery
- ECOG performance status score of 0 or 1
- No prior chemotherapy for non-small cell lung cancer before enrollment
- Laboratory tests within 7 days before enrollment meeting required blood counts and organ function levels
- Female participants must be menopausal, surgically sterilized, or using effective contraception and not breastfeeding
- Male participants must agree to use appropriate contraception
You will not qualify if you...
- Known or suspected allergy to the study drug or its components
- Eligible to receive targeted treatment
- History of other malignant tumors within 5 years, except certain cured cancers
- Recent serious heart conditions such as myocardial infarction or unstable angina
- Uncontrolled hypertension despite treatment
- History of HIV infection or active hepatitis B or C infection
- Risk of bleeding as judged by the researcher
- Active severe infections
- Epilepsy requiring medication
- History of allogeneic organ transplantation
- Need for kidney dialysis
- Recent thrombotic or embolic events within 6 months
- Serious untreated wounds, ulcers, or fractures
- Presence of interstitial pneumonia
- Any malabsorption disease
- Any unstable disease that risks patient safety
- Drug abuse or significant medical, psychological, or social issues
- Participation in other clinical studies within 3 months
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until disease progression or unacceptable toxicity
Participants receive four 21-day cycles of chemotherapy combined with camrelizumab, followed by maintenance camrelizumab treatment.
Cycles every 3 weeks with ongoing maintenance dosing
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, China, 510515
Actively Recruiting
Research Team
D
Di Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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