RecruitingPhase 2NCT05825443

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

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

57 participants

Start Date

Apr 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an immunotherapy drug called camrelizumab to standard chemotherapy after surgery helps prevent non-small cell lung cancer (NSCLC) from coming back in patients with stage IIA–IIIA disease who cannot use targeted therapy. **You may be eligible if...** - You are 18–80 years old - You have had surgery for non-small cell lung cancer at stage IIA–IIIA - You are not eligible for targeted therapy (e.g., your tumor does not have EGFR, ALK, or similar mutations that have approved targeted drugs) - You have not had chemotherapy for lung cancer before - You have recovered from surgery and are ready for treatment within 3–8 weeks - Your ECOG performance status is 0 or 1 (you are fairly active and independent) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You are eligible for targeted therapy - You have had another cancer in the past 5 years (with some exceptions like cured skin or cervical cancers) - You have had a heart attack, serious heart condition, or uncontrolled high blood pressure recently - You have active HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

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(1)

Nanfang Hospital, Southern Medical University

Guandong, Guangdong, China

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NCT05825443


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