Preoperative immunotherapy for early-stage non-small cell lung cancer
Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response
This study is testing if giving a new type of immunotherapy before surgery can help people with early-stage non-small cell lung cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Drugs / interventions | Nivolumab, Relatlimab, prednisone, immunotherapy |
| Locations | 4 sites (Hasselt and 3 other locations) |
| Trial ID | NCT04205552 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of administering four weeks of preoperative immunotherapy using Nivolumab alone or in combination with Relatlimab in patients with resectable non-small cell lung cancer (NSCLC) at various stages. The approach focuses on patients eligible for curative surgical resection, assessing their response to the treatment before surgery. The study will monitor safety, tolerability, and potential efficacy of the treatment regimen in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed NSCLC at stages I B, II, or selected stage III A who are eligible for surgical resection.
Not a fit: Patients with active autoimmune diseases or those requiring systemic immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival rates for patients with early-stage non-small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with immunotherapy in NSCLC, suggesting that this approach may be beneficial, although this specific combination is being explored in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages I B, II and selected stage III A) * Eastern Cooperative Oncology Group (ECOG) ≤ 1 * Sufficient pulmonary function to undergo curative lung cancer surgery * Adequate hematological, hepatic and renal function parameters: * Sufficient cardiac left ventricular defined as left ventricular ejection fraction (LVEF) ≥ 50% documented either by echocardiography or multigated acquisition scan (MUGA) * Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures Exclusion Criteria: * Active or history of autoimmune disease or immune deficiency * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration * Subjects who have undergone organ transplant or allogeneic stem cell transplantation * Uncontrolled or significant cardiovascular disease * Patients with active neurological disease * Active malignancy or a prior malignancy within the past 3 years * Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication * Peripheral polyneuropathy NCI CTCAE Grade ≥ 2 * History of gastric perforation or fistulae in past 6 months * Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment. * The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS) or implantation of a venous port-system. * Any other concurrent preoperative antineoplastic treatment including irradiation * Pregnant/Breastfeeding women * Subjects with history of severe toxicity or life-threatening toxicity (grade 3 or 4) related to prior immune therapy * Prior treatment with Lymphocyte-activation gene 3 (LAG-3) targeting Agent * Previous treatment with Nivolumab or Relatlimab
Where this trial is running
Hasselt and 3 other locations
- Jessa Hospital Hasselt — Hasselt, Belgium (Recruiting)
- University Hospital Essen — Essen, Germany (Recruiting)
- Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Martin Schuler, Prof. Dr. — University Hospital, Essen
- Study coordinator: Chiara Nicolini, PhD
- Email: chiara.nicolini@uk-essen.de
- Phone: 0049 201 723 44708
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.