Combining camrelizumab with chemotherapy for lung cancer treatment

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 evaluates the effectiveness and safety of neoadjuvant camrelizumab combined with chemotherapy in patients with resectable stage IIIA and IIIB non-small cell lung cancer (NSCLC). Participants aged 18-75 with confirmed NSCLC will receive three cycles of camrelizumab alongside platinum-based chemotherapy, followed by surgery. The study will assess the pathologic complete response rate and major pathological response rate as primary endpoints, while also monitoring safety and progression-free survival. Additionally, biomarker analysis will be conducted through blood samples and imaging scans.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75
* Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
* Absence of EGFR, ALK, and ROS1 gene mutations
* Eastern Cooperative Oncology Group (ECOG) status 0-1
* Signed written informed consent prior to the implementation of any trial-related rocedures
* Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \> 5 x ULN, Bilirubin \> 1.5 х ULN

Exclusion Criteria:

* Patients diagnosed with any other malignant tumor
* Have received prior therapy with chemotherapy or immune checkpoint inhibitor
* Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
* Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
* A history of interstitial lung disease or non-infectious pneumonia
* Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
* Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
* Patients who have received allogeneic stem cell or solid organ transplantation
* Women during pregnancy or lactation

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Xue Meng, MD, PhD
• Email: mengxue5409@163.com
• Phone: +86-17653115602

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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.