Evidence map›Paper›PMID 41110693›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2026

Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: final overall survival analysis of the phase III ALEX study.

S Peters, R Camidge, R Dziadziuszko, S Gadgeel, A T Shaw, D-W Kim, M Pérol, D R Rosell, P Cheema, D Wan-Teck Lim and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. 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
  8. Article
  9. ALK-tyrosine kinase inhibitor resistance due to acquiredTranslational lung cancer research · 2026
    Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

S PetersCentre Hospitalier Universitaire Vaudois (CHUV) Oncology Department, Lausanne, Switzerland. Electronic address: solange.peters@chuv.ch.
R CamidgeUniversity of Colorado Comprehensive Cancer Center, Aurora, USA.
R DziadziuszkoDepartment of Oncology & Radiotherapy and Early Phase Clinical Trials Centre, Medical University of Gdańsk, Gdańsk, Poland.
S GadgeelKarmanos Cancer Institute, Detroit, USA.
A T ShawDana-Farber Cancer Institute, Boston, USA.
D-W KimDepartment of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of South Korea.
M PérolDepartment of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.
D R RosellIOR, Dr Rosell Oncology Institute, Dexeus University Hospital, Barcelona, Spain.
P CheemaUniversity of Toronto, William Osler Health System, Brampton, Canada.
D Wan-Teck LimDivision of Medical Oncology, National Cancer Center, Singapore, Singapore.
J J LinDepartment of Medicine, Massachusetts General Hospital, Boston, USA.
N PavlakisRoyal North Shore Hospital, Sydney University, Sydney, Australia.
J S AhnDepartment of Hematology & Oncology, Samsung Medical Center, Seoul, South Korea.
L ZhangSun Yet-sen University Cancer Center, Guangdong, China.
V HenschelF. Hoffmann-La Roche Ltd, Basel, Switzerland.
A A HiggersonF. Hoffmann-La Roche Ltd, Basel, Switzerland.
V McNallyRoche Products Ltd, Welwyn Garden City, UK.
I RooneyGenentech Inc., South San Francisco, USA.
A ScaloriRoche Products Ltd, Welwyn Garden City, UK.
V SmoljanovicF. Hoffmann-La Roche Ltd, Basel, Switzerland.
T MokState Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundALEX, a global, randomized, phase III trial evaluated alectinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). This final analysis provides mature overall survival (OS), duration of response (DOR) and long-term safety data. PATIENTS AND

methodsTreatment-naïve patients with stage III/IV ALK-positive NSCLC were randomly assigned to receive alectinib [600 mg twice daily (b.i.d.)] or crizotinib (250 mg b.i.d.) until disease progression, unacceptable toxicity, withdrawal, or death. Primary endpoint was investigator-assessed progression-free survival (previously reported). Key secondary endpoints included OS, DOR and safety.

resultsA total of 303 patients (alectinib, n = 152; crizotinib, n = 151) were enrolled. At the updated data cut-off (28 April 2025), after a median follow-up of 53.5 (alectinib) and 23.3 (crizotinib) months, median OS was 81.1 [95% confidence interval (CI) 62.3 months-not estimable] versus 54.2 (95% CI 34.6-75.6 months) months, respectively [hazard ratio (HR) 0.78; 95% CI 0.56-1.08]. Improvement in median OS was observed with alectinib in patients with and without central nervous system (CNS) metastases at baseline [with CNS metastases: 63.4 (n = 59) versus 30.9 (n = 53) months with alectinib versus crizotinib, respectively (HR 0.68; 95% CI 0.40-1.15); without CNS metastases: 94.0 (n = 93) versus 69.8 (n = 98) months (HR 0.87; 95% CI 0.58-1.32)]. Median DOR in confirmed responders was longer with alectinib (42.3 months, 95% CI 31.3-51.3 months) versus crizotinib [11.1 months, 95% CI 7.9-13.0 months (HR 0.41; 95% CI 0.30-0.56)]. Long-term safety (median duration of alectinib treatment, 28.1 months) remained consistent with earlier reports, with no new or unexpected safety concerns identified.

conclusionsThese final OS data show the sustained long-term systemic and intracranial efficacy of alectinib in the first-line treatment of ALK-positive NSCLC and confirm alectinib as a standard of care in this setting.

Indexed as

Anaplastic Lymphoma KinaseCarbazolesCarcinoma, Non-Small-Cell LungCrizotinibLung NeoplasmsPiperidinesProtein Kinase InhibitorsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedProgression-Free SurvivalSurvival RatealectinibALK protein, humanAnaplastic Lymphoma KinaseCarbazolesCrizotinibPiperidinesProtein Kinase InhibitorsalectinibALEXanaplastic lymphoma kinasenon-small cell lung canceroverall survival

Identifiers

PMID41110693

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.