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Immunotherapy before lung surgery shows promise in early trial
NCT ID NCT04205552
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested giving immunotherapy drugs (nivolumab alone or with relatlimab) for four weeks before surgery in 90 people with early-stage non-small cell lung cancer. The goal was to see if this approach is feasible and helps shrink tumors before removal. Results help determine the best drug combinations and immune responses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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90 people
The number who actually took part.
- Started
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Mar 2020
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jessa Hospital Hasselt
Hasselt, Belgium
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Netherlands Cancer Institute
Amsterdam, Netherlands
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Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
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University Hospital Essen
Essen, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New combo therapy aims to keep early lung cancer from returning
- Immunotherapy after surgery may keep early lung cancer at bay
- New drug combo aims to wipe out lung cancer before surgery
- New combo therapy aims to shrink lung tumors before surgery
- Chemo-Free combo shows promise in lung cancer trial