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NCT Number: NCT06241807

Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camrelizumab Plus Chemotherapy

Drug

Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5])

Primary outcomes

  1. Major Pathological Response Rate

    Time frame: From date of surgery to 14 days later

    No more than 10% of tumor cells were found in neoadjuvant surgical specimens

  2. Pathologic complete response rate

    Time frame: From date of surgery to 14 days later

    No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes

Secondary outcomes

  1. Adverse events

    Time frame: 24 weeks

    Number and percentage of cases of all adverse events

  2. Disease-free survival

    Time frame: 24 months

    The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason

Other outcomes

  1. Molecular imaging research and biomarker analysis

    Time frame: 20 weeks

    Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment

Study contacts

Contact information is provided by the study sponsor or research team.

Guoxin Cai, MD

CONTACT

[email protected]

+33-751440039

Xue Meng, MD, PhD

CONTACT

[email protected]

+86-17653115602

Sponsors and collaborators

Lead sponsor

Shandong Cancer Hospital and Institute

Other

Registry information

Official study title

A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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