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Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response (NEOpredict-Lung)
EU CTIS ID: 2024-513074-22-00
What this study is testing
The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with nivolumab, nivolumab plus relatlimab at different dosis in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with histologically (core biopsy) or cytologically (e.g. bronchoscopy-guided biopsy) confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection, with the following specifications: o Clinical stages I B, II and selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board) according to UICC 8th edition
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
- Males and females, ages ≥ 18 years, inclusive o Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study treatment. o Women of childbearing potential (WOCBP) must agree to follow instructions for highly effective method(s) of contraception for the duration of treatment with study medication plus 5 months after the last dose of the study drug.
- ECOG ≤ 1
- Exclusion of extensive mediastinal lymph node metastases (multilevel N2, N3) by PET/CT and/or invasive mediastinal lymph node staging by EBUS-TBNA and/or staging mediastinoscopy as indicated by current guidelines.
- Exclusion of distant metastases by standard of care imaging studies, which include but are not limited to PET/CT or PET/MRI, or CT or MRI of thorax, abdomen, pelvis, and bone scan. Asymptomatic brain metastases will be excluded by MRI or contrast-enhanced CT as indicated by current guidelines
You likely can't join if
- Active or history of autoimmune disease or immune deficiency
- Troponin T (TnT) or I (TnI) > 2 × institutional upper limit of normal (ULN). Subjects with TnT or TnI levels between > 1 to 2 × ULN will be permitted if repeat levels within 24 hours are within ULN. If TnT or TnI levels are >1 to 2 × ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment, following a discussion with the coordinating investigator or designee. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 x ULN, the subject may undergo a cardiac evaluation and be considered for treatment, following a discussion with the coordinating investigator or designee
- Patients with active neurological disease should be excluded
- Active malignancy or a prior malignancy within the past 3 years. Patients with the following conditions are not excluded from participation:[..]
- Known history of positive test for human immunodeficiency virus (HIV-1 and HIV-2) or known acquired immunodeficiency syndrome (AIDS). [..]
- Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen positive, or hepatitis C antibody [..]
See the full eligibility criteria
Who can join
- Patients with histologically (core biopsy) or cytologically (e.g. bronchoscopy-guided biopsy) confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection, with the following specifications: o Clinical stages I B, II and selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board) according to UICC 8th edition
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
- Males and females, ages ≥ 18 years, inclusive o Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study treatment. o Women of childbearing potential (WOCBP) must agree to follow instructions for highly effective method(s) of contraception for the duration of treatment with study medication plus 5 months after the last dose of the study drug.
- ECOG ≤ 1
- Exclusion of extensive mediastinal lymph node metastases (multilevel N2, N3) by PET/CT and/or invasive mediastinal lymph node staging by EBUS-TBNA and/or staging mediastinoscopy as indicated by current guidelines.
- Exclusion of distant metastases by standard of care imaging studies, which include but are not limited to PET/CT or PET/MRI, or CT or MRI of thorax, abdomen, pelvis, and bone scan. Asymptomatic brain metastases will be excluded by MRI or contrast-enhanced CT as indicated by current guidelines
- Measurable target tumor prior to immunotherapy using standard imaging techniques
- Sufficient pulmonary function to undergo curative lung cancer surgery, ppFEV1>30%, ppDLCO>30%, ppVO2max ≥ 10 ml/min/kg (if CPET was mandated per local guidelines)
- Adequate hematological, hepatic and renal function parameters: [...]
- Sufficient cardiac left ventricular defined as LVEF ≥ 50% documented either by echocardiography or MUGA (echocardiography preferred test, MUGA not used in German site) within 6 months before first administration of study drug
What rules you out
- Active or history of autoimmune disease or immune deficiency
- Troponin T (TnT) or I (TnI) > 2 × institutional upper limit of normal (ULN). Subjects with TnT or TnI levels between > 1 to 2 × ULN will be permitted if repeat levels within 24 hours are within ULN. If TnT or TnI levels are >1 to 2 × ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment, following a discussion with the coordinating investigator or designee. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 x ULN, the subject may undergo a cardiac evaluation and be considered for treatment, following a discussion with the coordinating investigator or designee
- Patients with active neurological disease should be excluded
- Active malignancy or a prior malignancy within the past 3 years. Patients with the following conditions are not excluded from participation:[..]
- Known history of positive test for human immunodeficiency virus (HIV-1 and HIV-2) or known acquired immunodeficiency syndrome (AIDS). [..]
- Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen positive, or hepatitis C antibody [..]
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- 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
- 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.
- The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic VATS or implantation of a venous port-system
- Any other concurrent preoperative antineoplastic treatment including irradiation
- Pregnant women
- Breastfeeding women
- Insufficient cardiac left ventricular function defined as LVEF<50% by echocardiography (outside Germany: or MUGA scan) within 6 months before first administration of study drug
- A confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- Subjects with history of severe toxicity or life-threatening toxicity (grade 3 or 4) related to prior immune therapy (e.g.[..] except those that are unlikely to re-occur with standard countermeasures [..]
- Subjects with history of severe or life-threatining (grade 3 or 4) infusion-related reactions to prior immune therapy
- Prior treatment with LAG-3 targeting agent
- Participation in another interventional clinical study within the last 3 months prior to inclusion or simultaneous participation in other clinical studies
- Subjects who have undergone organ transplant or allogeneic stem cell transplantation
- Previous treatment with nivolumab or relatlimab
- Previous immunotherapy for lung cancer
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
- Any contraindications against nivolumab or relatlimab
- ppFEV1<30%, ppDLCO<30%, ppVO2max < 10 ml/min/kg (if CPET was mandated per local guidelines)
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: [..]
- History of other clinically significant cardiovascular disease (i.e.[..])
- Cardiovascular disease-related requirement for daily supplemental oxygen
- History of two or more myocardial infarctions or two or more coronary revascularization procedures
- Subjects with history of myocarditis, regardless of etiology
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.