Combination of nivolumab and ipilimumab before surgery for lung cancer

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 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.

Why it matters

Who can join: the full rules

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 it's running

• First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Shuben Li, Professor
• Email: 13500030280@163.com
• Phone: 020-8306-2114

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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.