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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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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: Soria, Jean-Charles
Tan, Daniel S W
Chiari, Rita
Wu, Yi-Long
Paz-Ares, Luis
Geater, Sarayut L
Cortinovis, Diego
Yu, Chong-Jen
Hochmair, Maximillian
Cortot, Alexis B
Tsai, Chun-Ming
Campelo, Rosario G
Branle, Fabrice
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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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

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