Evidence map›Paper›PMID 29959809›Full record

Trial reportCancer science2018

Phase II study of ceritinib in alectinib-pretreated patients with anaplastic lymphoma kinase-rearranged metastatic non-small-cell lung cancer in Japan: ASCEND-9.

Toyoaki Hida, Takashi Seto, Hidehito Horinouchi, Makoto Maemondo, Masayuki Takeda, Katsuyuki Hotta, Fumihiko Hirai, Young Hak Kim, Shingo Matsumoto, Masayuki Ito and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02450903 (A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT02450903 phase2completednot on this map

A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2018Enrolled20ConditionsNon-Small-Cell Lung CancerArmsLDK378
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Efficacy and safety of second-line treatments in ALK mutation-positive advanced non-small cell lung cancer after second- or third-generation ALK inhibitors: Turkish Oncology Group real-life study (TOG study).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Alectinib continuation beyond progression inTranslational lung cancer research · 2024
    Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Toyoaki HidaAichi Cancer Center Hospital, Aichi, Japan.ORCID http://orcid.org/0000-0003-3537-0020
Takashi SetoNational Kyushu Cancer Center, Fukuoka, Japan.
Hidehito HorinouchiNational Cancer Center Hospital, Tokyo, Japan.
Makoto MaemondoMiyagi Cancer Center, Miyagi, Japan.
Masayuki TakedaKindai University, Osaka, Japan.
Katsuyuki HottaOkayama University Hospital, Okayama, Japan.
Fumihiko HiraiNational Kyushu Cancer Center, Fukuoka, Japan.
Young Hak KimKyoto University Hospital, Kyoto, Japan.
Shingo MatsumotoNational Cancer Center Hospital East, Kashiwa, Japan.
Masayuki ItoNovartis Pharma K.K., Tokyo, Japan.
Koichi AyukawaNovartis Pharma K.K., Tokyo, Japan.
Kota TokushigeNovartis Pharma K.K., Tokyo, Japan.
Masataka YonemuraNovartis Pharma K.K., Tokyo, Japan.
Testuya MitsudomiKindai University, Osaka, Japan.
Makoto NishioThe Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Funding

Novartis Pharma K.K.
6 · The paper itself

Abstract

Clinical experience of ceritinib in patients who progressed on alectinib is limited. In this prospective phase II study, we evaluated the activity of ceritinib in alectinib-pretreated patients with anaplastic lymphoma kinase (ALK)-rearranged metastatic (stage IIIB/IV) non-small-cell lung cancer (NSCLC) in Japan. All patients were required to have ≥1 measurable lesion per RECIST, 1.1, and a World Health Organization Performance Status (WHO PS) of 0-1. Prior crizotinib and/or up to 1 chemotherapy regimen was allowed. Primary endpoint was investigator-assessed overall response rate (ORR) per RECIST 1.1. Ceritinib was given at a dose of 750 mg/day fasted. A total of 20 patients were enrolled from August 2015 to March 2017. All patients received prior alectinib (100%), 13 (65.0%) patients received prior platinum-based chemotherapy, and 4 (20%) patients received prior crizotinib. Median duration of exposure and the follow-up time with ceritinib were 3.7 months (range: 0.4-15.1) and 11.6 months (range: 4.8-23.0), respectively. Investigator-assessed ORR was 25% (95% CI: 8.7-49.1). Key secondary endpoints, all investigator assessed, included disease control rate (70.0%; 95% CI: 45.7-88.1), time to response (median, 1.8 months; range: 1.8-2.0), and duration of response (median, 6.3 months; 95% CI: 3.5-9.2). Median progression-free survival was 3.7 months (95% CI: 1.9-5.3). The most common adverse events reported were diarrhea (85.0%), nausea (80.0%), and vomiting (65.0%). Based on our findings, ceritinib could be considered as one of the treatment options for patients with ALK-positive NSCLC who progressed on alectinib. (Trial registration no. NCT02450903).

Indexed as

Gene RearrangementAdultAgedAnaplastic Lymphoma KinaseAntineoplastic AgentsCarbazolesCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedPiperidinesPyrimidinesReceptor Protein-Tyrosine KinasesSulfonesalectinibALK protein, humanAnaplastic Lymphoma KinaseAntineoplastic AgentsCarbazolesceritinibPiperidinesPyrimidinesReceptor Protein-Tyrosine KinasesSulfonesALKanaplastic lymphoma kinaseceritinibJapanNSCLC

Identifiers

PMID29959809
PMCPMC6125456

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.