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Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2017-12-29
View on ClinicalTrials.gov ↗

Amendment history

2026-03-20
Study Status v38
Primary completion date2026-03-31→2027-03-31
Completion date2026-03-31→2027-03-31
2025-12-11
Study Status v37
Primary completion date2025-12-31→2026-03-31
Completion date2025-12-31→2026-03-31
2025-11-06
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v36
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 400→confirmed 339
Study sitesdetails revised at 5 of 5 sites
2025-05-09
2 amendments v34-v35
2 re-verifications since 2025-03-05, no change to tracked fields
2024-10-22
Study Identification, Study Status, Oversight, Conditions, Eligibility, Contacts/Locations v33
Eligibility criteria+10 characters
[...] teria in Solid Tumors (RECIST) 1.1. Signed and dated written or remote informed consent prior to admission to the study in accorda [...]
Study sitescontacts updated at 5 of 5 sites
Study titlerevised
Nivolumab and Ipilimumab withWith or Without Local Consolidation Therapy in Treating Patients withWith Stage IV Non-Small Cell Lung Cancer
Show 32 earlier versions
2024-09-13
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v32
Study sitescontacts updated at 5 of 5 sites
Study titlerevised
Nivolumab and Ipilimumab Withwith or Without Local Consolidation Therapy in Treating Patients Withwith Stage IV Non-Small Cell Lung Cancer
2024-07-03
2 amendments v30-v31
2 re-verifications since 2024-05-02, no change to tracked fields
2024-03-20
Study Status, Eligibility v29
Eligibility criteria+3,967 characters
[...] . bevacizumab) is permitted if used as frontline treatment. Patients must have organ and marrow function as defined below: Performance status of 0 or 1 if using Eastern Cooperative Oncology Group (ECOG)/Zubrod. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to treatment initiation White blood cell (WBC ) >= 2000/uL (obtained within 14 days prior to randomization/registration) Neutrophils >= 1500/uL (obtained within 14 days prior to ra [...] days prior to randomization/registration) Serum creatinine =<≤ 1.5 x upper limit of normal (ULN) or cre [...] [...]
2023-10-31
Study Status v28
Re-verified, no change to tracked fields
2023-10-18
Study Status v27
Primary completion date2023-12-31→2025-12-31
Completion date2023-12-31→2025-12-31
2023-10-18
Study Status, Study Design v26
Enrollment target360→400
2023-10-05
3 amendments v23-v25
3 re-verifications since 2023-08-24, no change to tracked fields
2022-12-05
Study Status v22
Primary completion date2022-12-31→2023-12-31
Completion date2022-12-31→2023-12-31
2022-11-08
2 amendments v20-v21
2 re-verifications since 2022-05-25, no change to tracked fields
2021-10-25
Study Status, Contacts/Locations v19
Study sites6→5
2021-03-02
Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Eligibility v18
Enrollment target270→360
Eligibility criteria+86 characters
[...] o the American Joint Committee on Cancer [AJCC] 8th edition) measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Signed and dated written informed consent prior to admissi [...] ives Women must not be breastfeeding. Patients excluded with any prior treatment of pneumonitis requiring corticosteroids wi [...]
Secondary endpoints-260 characters
Progression-Free Survival (PFS) Time to Appearance of New Metastases (TANM) Progression of Target lesions Defined by RECIST 1.1 Criteria Progression of Non-Target Lesions by RECIST 1.1 Criteria Toxicity Evaluated Using CTCAE v4.0 Criteria Quality of Life (QOL)
Collaborators-31 characters
National Cancer Institute (NCI)
Study title+75 characters
Phase III Trial of (LCT) After Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
2021-02-08
3 amendments v15-v17
3 re-verifications since 2020-07-21, no change to tracked fields
2019-12-06
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v14
Eligibility criteria+101 characters
[...] egislation. For lung adenocarcinoma patients, patients must benot wild-typeharbor forany EGFR andsensitizing or ALK fusion where there are standard care therapy options available. For patients with histologies other than adenocarcinoma, E [...] th ROS1/RET alterations can be enrolled, as tyrosine kinase inhibitorsinhibitor (TKIs)/such as crizotinib aren't established as first line therapy for pati [...] Total Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndromesyndrome, who can have total bilirubin < 3.0 mg/dL) (obtained within [...] table (except for residual signs or symptoms related to the central ner [...] [...]
Study description+4 characters
[...] h nivolumab and ipilimumab with or without LCT. EXPLORATORY OBJECTIVESOBJECTIVE: I. To identify novel prognostic and predictive markers pre [...] UCTION PHASE: Patients receive nivolumab intravenously (IV) 60over 90 minutes on days 1, 15, and 29, and ipilimumab IV over 9060 minutes on day 1. Treatment repeats every 6 weeks for up to [...] re followed up at 8 weeks and then every 3 months for up to 31 year.
Study sites6 entries, revised
MD Anderson Regionalin CareThe Center-KatyWoodlands MD Anderson RegionalWest Care Center-Bay AreaHouston MD Anderson RegionalLeague Care Center-Sugar LandCity MD Anderson Regionalin CareSugar Center-The WoodlandsLand
2019-10-31
4 amendments v10-v13
4 re-verifications since 2019-07-15, no change to tracked fields
2019-04-22
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v9
Eligibility criteria+310 characters
[...] . Subjects with brain metastases are eligible if metastases haveare beenadequately treated and theresubjects isare noneurologically magnetic resonance imagingstable (MRI) evidence of diseaseexcept for 4residual signs or symptoms related to the CNS treatment) for at least 2 weeks after treatment is complete and within 28 days prior to the first dose of nivolumab. SubjectsIn addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of nivolumab. Patients with asymptomatic, smal [...] [...]
Study description-5 characters
[...] UCTION PHASE: Patients receive nivolumab intravenously (IV) over 9060 minutes on days 1, 15, and 29, and ipilimumab IV over 6090 minutes on day 1. Treatment repeats every 6 weeks for up to [...] re followed up at 8 weeks and then every 3 months for up to 13 year.
Study title-11 characters
Phase III Trial of (LCT) After Nivolumab and Ipilimumab (LONESTAR)
2019-04-11
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v8
Primary completion date2022-12→2022-12-31
Completion date2022-12→2022-12-31
InterventionsIpilimumab (Drug), Local Consolidative Therapy (LCT) (Procedure), Nivolumab (Drug)→Ipilimumab (Biological), Local Consolidation Therapy (Procedure), Nivolumab (Biological), Quality-of-Life Assessment (Other), Radiation…
Eligibility criteria+418 characters
Inclusion Criteria: Age >/= 18 Histologically or cytologically confirmed non-small cell lung cancer. If; if a diagnostic biopsy is available, a pre-treatment biopsy is [...] tiating treatment on study. Neuroendocrine carcinomas (e.g. small cell lung cancer [SCLC], carcinoid tumors) are not eligible. Carcinomas with neuroe [...] ocrine differentiation are eligible. Stage IV (according to the American Joint Committee on Cancer [AJCC] 8th edition). Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-G [...] [...]
Primary endpoints2 entries, revised
OverallOS Survivalin (OS)oligometastatic subgroup Overall Survivalsurvival (OS) in Oligometastaticoverall Patientspopulation
Study description+4,021 characters
PRIMARY OBJECTIVES: I. To determine whether local consolidative therapy (LCT; radiotherapy +/- surgical resection, radiofrequency ablation, or cryoablation for up to 3 lesions) followed by up to 2 years of treatment with ipilimumab (1mg/Kg every 6 weeks) and nivolumab (3 mg/Kg, every 2 weeks) prolon [...]
Study sites6 entries, revised
MDMemorial Anderson Cancer CenterHermann Memorial City Medical Center UniversityM of Texas MDD Anderson Cancer Center MD Anderson CancerRegional Care Center-Katy MD Anderson CancerRegional Care Center-Bay Area MD Anderson CancerRegional Care Center-Sugar Land MD Anderson CancerRegional Care Center-The Woodlands
Collaborators1 entry, revised
Bristol-MyersNational SquibbCancer Institute (NCI)
Study title-18 characters
Phase III Trial of Local Consolidation Therapy (LCT) After Nivolumab and Ipilimumab (LONESTAR)
2018-11-21
Study Status v7
Re-verified, no change to tracked fields
2018-11-02
Study Status, Study Description v6
Completion date2023-12→2022-12
Study description-6,774 characters
Study Groups: If you are found to be eligible to take part in the study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 treatment arms. This is done because no one knows if one group is better, the same, or worse than the other. If you are in Arm A, you will receive ipilimumab an [...]
2018-06-21
Study Status v5
Re-verified, no change to tracked fields
2018-05-09
Study Identification, Study Status, Study Description, Eligibility v4
Eligibility criteria-25 characters
[...] s have been treated and there is no MRI evidence of disease progression for 4 weeks after treatment is complete and within 28 days p [...] s (HIV) or known acquired immunodeficiency syndrome (AIDS). Allergies and Adverse Drug Reaction. History of allergy to study drug components. History of seve [...]
Study description-401 characters
Study Groups: If participantyou isare found to be eligible to take part in the study, participantyou will be randomly assigned (as in the flip of a coin) to 1 o [...] one group is better, the same, or worse than the other. If participantyou isare in Arm A, participantyou will receive ipilimumab and nivolumab. If participantyou isare in Arm B, participantyou will receive LCT plus ipilimumab and nivolumab. ParticipantYou will have an equal chance (50/50) of being assigned to either arm. The study doctor will tell participantyou to which arm participantyou hashave been assigned. Before participantyou i [...] [...]
2018-02-12
Study Status v3
Re-verified, no change to tracked fields
2018-02-06
Study Status, Contacts/Locations v2
Completion date2022-12→2023-12
Study sites1→6
2018-01-04
Study Status, Study Description v1
Study description+649 characters
Study Groups: If youparticipant areis found to be eligible to take part in the study, youparticipant will be randomly assigned (as in the flip of a coin) to 1 o [...] one group is better, the same, or worse than the other. If youparticipant areis in Arm A, youparticipant will receive ipilimumab and nivolumab. If youparticipant areis in Arm B, youparticipant will receive LCT plus ipilimumab and nivolumab. YouParticipant will have an equal chance (50/50) of being assigned to either arm. The study doctor will tell youparticipant to which arm youparticipant havehas been assigned. Before youparticipant a [...] [...]
2018-01-02
Original filing
This phase III trial studies how well nivolumab and ipilimumab works with or without local consolidation therapy in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Local consolidation therapy, such as surgery or radiation therapy, may improve survival outcomes in patients with non-small cell lung cancer. It is not yet known whether giving nivolumab and ipilimumab with local consolidation therapy works better than nivolumab and ipilimumab alone in treating patients with stage IV non-small cell lung cancer.
Trial Details
NCT Number NCT03391869
Lead Sponsor M.D. Anderson Cancer Center
Conditions Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Enrollment 339 participants
Start Date 2017-12-29
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-18