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Immunotherapy before lung surgery shows promise in early trial

NCT ID NCT04205552

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Mar 2020

Finished

Nov 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Jessa Hospital Hasselt

    Hasselt, Belgium

  • Netherlands Cancer Institute

    Amsterdam, Netherlands

  • Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • University Hospital Essen

    Essen, Germany

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