Evidence map›Paper›PMID 35091443›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2022

ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges.

Laura Q M Chow, Fabrice Barlesi, Erin M Bertino, Martin J van den Bent, Heather A Wakelee, Patrick Y Wen, Chao-Hua Chiu, Sergey Orlov, Rita Chiari, Margarita Majem and 9 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02336451 (A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02336451 phase2completednot on this map

A Phase II, Multi-center, Open-label, Five-arm Study to Evaluate the Efficacy and Safety of Oral Ceritinib Treatment for Patients With ALK-positive Non-small Cell Lung Cancer (NSCLC) Metastatic to the Brain and/or to Leptomeninges

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2019Enrolled156ConditionsALK-positive Non-small Cell Lung CancerArmsCeritinib
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 43 citations in OpenAlex.

  1. Article
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  10. EML4-ALK: Update on ALK Inhibitors.International journal of molecular sciences · 2025
    Review
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  18. ATM-Inhibitor AZD1390 Is a Radiosensitizer for Breast Cancer CNS Metastasis.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 16 institutions in 10 countries.

Laura Q M ChowUniversity of Washington, Seattle, Washington and University of Texas at Austin, Dell Medical School, Department of Oncology, Austin, Texas.ORCID 0000-0002-7237-017X
Fabrice BarlesiAix-Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.
Erin M BertinoThe Ohio State University Comprehensive Cancer Centre, Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, Ohio.ORCID 0000-0003-3174-0928
Martin J van den BentDepartment of Neurology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.ORCID 0000-0001-5710-5127
Heather A WakeleeStanford University, Stanford, California.ORCID 0000-0003-1136-980X
Patrick Y WenDepartment of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts.
Chao-Hua ChiuDepartment of Chest Medicine, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan.
Sergey OrlovState Pavlov Medical University, St. Petersburg, Russia.
Rita ChiariDepartment of Oncology, AULSS6 Euganea, Padova, Italy.
Margarita MajemHospital de La Santa Creu I Sant Pau, Barcelona, Spain.ORCID 0000-0002-9919-7485
Mark McKeageUniversity of Auckland, Auckland, New Zealand.
Chong-Jen YuDepartment of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Pilar GarridoDepartment of Medical Oncology, Hospital Universitario Ramon Y Cajal, Madrid, Spain.ORCID 0000-0002-5899-6125
Felipe K HurtadoNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.ORCID 0000-0002-5254-972X
Pilar Cazorla ArratiaNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Yuanbo SongNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Fabrice BranleNovartis Pharma AG, Basel, Switzerland.
Michael ShiNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.ORCID 0000-0001-5124-7132
Tris Pharma (United States) · USCentre National de la Recherche Scientifique · FRDana-Farber Cancer Institute · USErasmus MC Cancer Institute · NLFirst Pavlov State Medical University of St. Petersburg · RUHospital de Sant Pau · ESHospital Universitario Ramón y Cajal · ESNational Taiwan University Hospital · TWNational Yang Ming Chiao Tung University · TWNovartis (Switzerland) · CHSeoul National University Hospital · KRStanford University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USUniversity of Auckland · NZUniversity of Padua · ITUniversity of Washington Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCentral nervous system metastases are a prominent cause of morbidity and mortality in patients with ALK-positive (ALK+) non-small cell lung cancer (NSCLC). The phase II ASCEND-7 (NCT02336451) study was specifically designed to assess the efficacy and safety of the ALK inhibitor (ALKi) ceritinib in patients with ALK+ NSCLC metastatic to the brain and/or leptomeninges. PATIENTS AND

methodsPatients with active brain metastases were allocated to study arms 1 to 4 based on prior exposure to an ALKi and/or prior brain radiation (arm 1: prior radiotherapy/ALKi-pretreated; arm 2: no radiotherapy/ALKi-pretreated; arm 3: prior radiotherapy/ALKi-naïve; arm 4: no radiotherapy/ALKi-naïve). Arm 5 included patients with leptomeningeal carcinomatosis. Patients received ceritinib 750 mg once daily (fasted condition). Primary endpoint was investigator-assessed whole-body overall response rate (ORR) per RECIST v1.1. Secondary endpoints included disease control rate (DCR) and intracranial/extracranial responses.

resultsPer investigator assessment, in arms 1 (n = 42), 2 (n = 40), 3 (n = 12), and 4 (n = 44), respectively: whole-body ORRs [95% confidence interval (CI)] were 35.7% (21.6-52.0), 30.0% (16.6-46.5), 50.0% (21.1-78.9), and 59.1% (43.2-73.7); whole-body DCR (95% CI): 66.7% (50.5-80.4), 82.5% (67.2-92.7), 66.7% (34.9-90.1), and 70.5% (54.8-83.2); intracranial ORRs (95% CI): 39.3% (21.5-59.4), 27.6% (12.7-47.2), 28.6% (3.7-71.0), and 51.5% (33.5-69.2). In arm 5 (n = 18), whole-body ORR was 16.7% (95% CI, 3.6-41.4) and DCR was 66.7% (95% CI, 41.0-86.7). Paired cerebrospinal fluid and plasma sampling revealed that ceritinib penetrated the human blood-brain barrier.

conclusionsCeritinib showed antitumor activity in patients with ALK+ NSCLC with active brain metastases and/or leptomeningeal disease, and could be considered in the management of intracranial disease. See related commentary by Murciano-Goroff et al., p. 2477.

Indexed as

Brain NeoplasmsCarcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasms, Second PrimaryAnaplastic Lymphoma KinaseBrainCentral Nervous SystemHumansProtein Kinase InhibitorsPyrimidinesSulfonesAnaplastic Lymphoma KinaseceritinibProtein Kinase InhibitorsPyrimidinesSulfones

Identifiers

PMID35091443
OpenAlexW4210476483

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.