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Cited by 1,151Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

The DOI matches its Crossref record; 25 of the 26 references it cites were found in a registry or an index.

First-line ceritinib versus platinum-based chemotherapy in advanced ALK -rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study

Soria, Jean-Charles, Tan, Daniel S W, Chiari, Rita, Wu, Yi-Long, Paz-Ares, Luis, Wolf, Juergen, Geater, Sarayut L, Orlov, Sergey, Cortinovis, Diego, Yu, Chong-Jen, Hochmair, Maximillian, Cortot, Alexis B, Tsai, Chun-Ming, Moro-Sibilot, Denis, Campelo, Rosario G, McCulloch, Tracey, Sen, Paramita, Dugan, Margaret, Pantano, Serafino, Branle, Fabrice, Massacesi, Cristian, de Castro, Gilberto·2017·The Lancet
DOI 10.1016/s0140-6736(17)30123-x
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Abstract

Background The efficacy of ceritinib in patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) is not known. We assessed the efficacy and safety of ceritinib versus platinum-based chemotherapy in these patients. Methods This randomised, open-label, phase 3 study in untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC was done in 134 centres across 28 countries. Eligible patients were assigned via interactive response technology to oral ceritinib 750 mg/day or platinum-based chemotherapy ([cisplatin 75 mg/m 2 or carboplatin AUC 5-6 plus pemetrexed 500 mg/m 2 ] every 3 weeks for four cycles followed by maintenance pemetrexed); randomisation was stratified by World Health Organization performance status (0 vs 1-2), previous neoadjuvant or adjuvant chemotherapy, and presence of brain metastases as per investigator's assessment at screening. Investigators and patients were not masked to treatment assignment. The primary endpoint was blinded independent review committee assessed progression-free survival, based on all randomly assigned patients (the full analysis set). Efficacy analyses were done based on the full analysis set. All safety analyses were done based on the safety set, which included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT01828099. Findings Between Aug 19, 2013, and May 11, 2015, 376 patients were randomly assigned to ceriti…

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Metadata

Authors
Soria, J.-C., Tan, D. S. W., Chiari, R., Wu, Y.-L., Paz-Ares, L., Wolf, J., Geater, S. L., Orlov, S., Cortinovis, D., Yu, C.-J., Hochmair, M., Cortot, A. B., Tsai, C.-M., Moro-Sibilot, D., Campelo, R. G., McCulloch, T., Sen, P., Dugan, M., Pantano, S., Branle, F., Massacesi, C., & de Castro, G.
Affiliations
  • Université Paris-Sud (FR)
  • National Cancer Centre Singapore (SG)
  • Azienda Ospedaliera di Perugia (IT)
  • Guangdong General Hospital (CN)
  • Universidad Complutense de Madrid (ES)
  • University Hospital Cologne (DE)
  • Songklanagarind Hospital (TH)
  • Azienda Ospedaliera San Gerardo (IT)
  • National Taiwan University Hospital (TW)
  • Otto Wagner Hospital (AT)
  • Centre Hospitalier Universitaire de Lille (FR)
  • Taipei Veterans General Hospital (TW)
  • Universidade da Coruña (ES)
  • Novartis (Switzerland) (CH)
Corresponding author
Soria, Jean-Charles
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2017-03
Volume
389
Issue
10072
Pages
917-929
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(17)30123-x
OpenAlex
W2581996620
Cited by
1,151
References
26
Citations by year
2026: 38 · 2025: 73 · 2024: 98 · 2023: 123 · 2022: 142 · 2021: 128 · 2020: 139 · 2019: 146 · 2018: 168 · 2017: 94
FWCI
123.94
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
  • BOA (University of Milano-Bicocca) (submittedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
  • Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords
ceritinib, anaplastic lymphoma kinase, ALK-positive non-small cell lung cancer, first-line therapy, platinum-based chemotherapy, pemetrexed, progression-free survival, targeted therapy, adverse events, diarrhea, elevated liver enzymes, brain metastases, treatment safety and efficacy comparison, WHO performance status
MeSH terms
Pemetrexed, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Female, Humans, Lung Neoplasms, Male, Middle Aged, Pyrimidines, Sulfones, Carboplatin, Treatment Outcome, Disease-Free Survival, Kaplan-Meier Estimate, Young Adult

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