Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

Titre officiel

A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

Sommaire:

Cet essai de phase III à répartition aléatoire vise à comparer l’administration de nivolumab et d’ipilimumab en association à l’administration de nivolumab seul pour traiter des patients atteints d’un cancer du poumon à cellules squameuses de stade IV qui est réapparu après un traitement antérieur. Il s’agit d’une sous-étude « sans appariement » qui inclut tous les patients sélectionnés n’étant pas admissibles à une sous-étude axée sur les biomarqueurs. Les anticorps monoclonaux, tels que le nivolumab et l’ipilimumab, pourraient réduire la taille des tumeurs. On ignore toujours si le nivolumab est plus efficace avec ou sans ipilimumab pour traiter les patients atteints d’un cancer du poumon à cellules squameuses.

Description de l'essai

Primary Outcome:

  • Investigator-assessed progression-free survival as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (Design #1, Phase II)
  • Less than 33% improvement in median investigator-assessed progression-free survival as defined as Response Evaluation Criteria in Solid Tumours version 1.1 (Design #1, Phase III)
  • Overall survival
  • Overall survival (Design #1, Phase III)
Secondary Outcome:
  • Investigator-assessed progression-free survival, censoring patients with symptomatic deterioration at the time of symptomatic deterioration (Design #1, Phase III)
  • Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (Design #1, Phase II and III)
  • Toxicity frequencies, monitored using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Design #1, Phase II and III)
PRIMARY OBJECTIVES:
I. To compare overall survival (OS) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung randomized to nivolumab plus ipilimumab versus nivolumab. SECONDARY OBJECTIVES:
I. To compare investigator-assessed progression-free survival (IA-PFS) in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab versus nivolumab. II. To compare the response rates (confirmed and unconfirmed, complete and partial) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab. III. To compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab. IV. To evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab versus nivolumab. TRANSLATIONAL MEDICINE OBJECTIVES:
I. To evaluate if there is a differential treatment effect on OS, IA-PFS, and response by tumour programmed death-ligand 1 (PD-L1) expression status. II. To examine patient reported outcomes by treatment arm. OUTLINE:

Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment but prior to disease progression, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years. After disease progression, patients are followed up every 6 months for 2 years and at end of year 3 after sub-study registration.

Voir cet essai sur ClinicalTrials.gov

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