Combining camrelizumab with chemotherapy for lung cancer treatment
A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
This study is testing if combining a new drug called camrelizumab with chemotherapy can help people with certain types of lung cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy, camrelizumab |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06241807 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with resectable stage IIIA-IIIB NSCLC and no specific gene mutations.
Not a fit: Patients with other malignancies or those who have previously received chemotherapy or immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xue Meng, MD, PhD
- Email: mengxue5409@163.com
- Phone: +86-17653115602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.