Combination of nivolumab and ipilimumab before surgery for lung cancer

Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer

This study is testing a combination of two immunotherapy drugs, nivolumab and ipilimumab, before surgery to see if it helps people with advanced lung cancer do better than traditional treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Drugs / interventions: nivolumab, ipilimumab, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06926790 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and feasibility of using neoadjuvant immunotherapy with nivolumab and ipilimumab in patients with locally advanced and resectable non-small cell lung cancer (NSCLC). The study aims to enroll 69 participants who will receive the combination treatment prior to surgery, with the primary endpoint being the rate of pathological complete response (pCR). The trial addresses the limitations of conventional chemotherapy, particularly in elderly patients and those with low PD-L1 expression. By focusing on immunotherapy, the study seeks to improve treatment outcomes and reduce toxicity associated with traditional approaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed non-small cell lung cancer, clinical stage II-IIIA, and PD-L1 expression of 1% or less.

Not a fit: Patients with active autoimmune diseases, prior treatments for lung cancer, or significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and survival rates for patients with locally advanced NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, but this specific approach in the neoadjuvant setting is still being evaluated.

Eligibility criteria

Inclusion Criteria:

1. Informed consent must be signed.
2. At least 18 years of age.
3. Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation).
4. Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%.
5. disease eligible for surgery.
6. No previous systematic therapy or radiotherapy.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. At least one measurable lesion.
9. No major organ dysfunction, including liver, kidney, and cardiac function.

Exclusion Criteria:

1. Patients with active autoimmune disease or history of autoimmune disease.
2. Patients have received other treatment for non-small cell lung cancer or for any other malignancy.
3. History of allergy to study drug components.
4. Pregnant or breast-feeding.
5. Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information.
6. Patients who have other malignancies.
7. History of major surgery or serious injury within the past 3 months.
8. HIV, HBV, HCV infection or active pulmonary tuberculosis.
9. Vaccination within 4 weeks prior to the start of the study.
10. Presence of underlying medical conditions that, in the investigator's judgment, could increase the risk associated with study drug administration or interfere with the assessment of toxicity and adverse events.

Where this trial is running

Guangzhou

• First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Shuben Li, Professor

Conditions Lung Cancer - Non Small Cell; lung cancer; nivolumab plus ipilimumab; neoadjuvant treatment; non-small cell lung cancer