NCT06241807RecruitingPhase 2
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 14 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Jan 2024
- Start date
- 2 Dec 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Lung cancer
- NCT number
- NCT06241807
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 2 Dec 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received prior therapy with chemotherapy or immune checkpoint inhibitor
- Patients who have received allogeneic stem cell or solid organ transplantation
Other illness
- Patients diagnosed with any other malignant tumor
- 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
Other
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- Women during pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.