Trials Annotator

Trial NCT02654587

View at ClinicalTrials.gov

Org. Study IDs: OSE2101C301
Secondary IDs: 2015-003183-36

Last trial update was posted on 2024-02-02

MeSH Interventions

Docetaxel Pemetrexed

MeSH Conditions

Carcinoma, Non-Small-Cell Lung Lung Neoplasms

Other Conditions

Non Small Cell Lung Cancer

Stopping Reasons

due to COVID-19

Limitations And Caveats

In April 2020 at time of planned interim analysis, decision was taken to prematurely stop the accrual due to COVID-19. Early termination led to small numbers of subject analyzed. The statistical plan was revised to propose the primary efficacy analysis in subgroup of patients with ICI secondary resistance (defined as progression after ICI second line >= to 12 weeks from stratification criteria based on biological and clinical rationale).

Result Publications

Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11. [PMID: 37704166] [DOI: 10.1016/j.annonc.2023.07.006]

Annotations

Category Annotations

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Intervention Annotations

#	Outdated	Intervention				Condition
#	Outdated	Name		Route	DrugBank ID	Condition