Evidence map›Paper›PMID 39639088›Full record

Trial reportBritish journal of cancer2025

Long term efficacy of first-line afatinib and the clinical utility of ctDNA monitoring in patients with suspected or confirmed EGFR mutant non-small cell lung cancer who were unsuitable for chemotherapy.

Sanjay Popat, Adam Januszewski, Mary O'Brien, Tanya Ahmad, Conrad Lewanski, Ulrike Dernedde, Petra Jankowska, Clive Mulatero, Riyaz Shah, Jonathan Hicks and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01415011 (Trial of Afatinib), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT01415011 phase2completednot on this map

Trial of Afatinib (BIBW 2992) in Suspected or Confirmed Mutant EGFR Lung Cancer Patients Unfit for Chemotherapy

TypeinterventionalSponsorUniversity College, LondonRan2012 to 2018Enrolled39ConditionsCarcinoma, Non-Small-Cell LungArmsAfatinib (BIBW 2992)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

21 authors.

Sanjay PopatThe Royal Marsden NHS Foundation Trust, London, UK.ORCID http://orcid.org/0000-0003-2087-4963
Adam JanuszewskiImperial College London and St Bartholomew's Hospital NHS Trust, London, UK.
Mary O'BrienThe Royal Marsden NHS Foundation Trust, London, UK.
Tanya AhmadRoyal Free London NHS Foundation Trust and University College London Hospitals NHS Foundation Trust, London, UK.
Conrad LewanskiImperial College London, London, UK.
Ulrike DerneddeJames Paget University Hospitals NHS Foundation Trust, Great Yarmouth, UK.
Petra JankowskaSomerset NHS Foundation Trust, Somerset, UK.
Clive MulateroLeeds Teaching Hospitals NHS Trust, Leeds, UK.
Riyaz ShahMaidstone and Tunbridge Wells NHS Trust, Maidstone, UK.
Jonathan HicksBeatson West of Scotland Cancer Centre, Glasgow, UK.
Tom GeldartUniversity Hospital Dorset NHS Foundation Trust, Poole, UK.
Mathilda CominosEast Kent Hospitals University NHS Foundation Trust, Canterbury, UK.
Gill GrayNorfolk and Norwich University Hospitals, Norwich, UK.
James SpicerKings College London, London, UK.ORCID http://orcid.org/0000-0003-3732-8491
Karen BellBeatson West of Scotland Cancer Centre, Glasgow, UK.
Simon RoittInivata Ltd, Cambridge, UK.
Clive MorrisInivata Ltd, Cambridge, UK.
Yenting NgaiCR UK & UCL Cancer Trials Centre, London, UK.
Laura HughesCR UK & UCL Cancer Trials Centre, London, UK.
Allan HackshawCR UK & UCL Cancer Trials Centre, London, UK.ORCID http://orcid.org/0000-0002-5570-5070
William WilsonCR UK & UCL Cancer Trials Centre, London, UK. william.wilson.13@ucl.ac.uk.

Funding

Boehringer Ingelheim Timely BIBW2992
6 · The paper itself

Abstract

backgroundHere we present long-term outcomes of first line afatinib in comorbid patients with suspected or confirmed EGFR mutant NSCLC otherwise considered unsuitable for chemotherapy, and the clinical utility of serial ctDNA monitoring.

methodsTIMELY (NCT01415011) was a multicentre, single arm, phase II trial conducted in the UK. Patients aged ≥18 were treated with daily oral afatinib (40 mg) until disease progression or unacceptable toxicity. Blood samples for ctDNA analysis were obtained at baseline and 12-weekly until treatment discontinuation. The primary endpoint was PFS.

resultsThirty-nine patients were enrolled between March 2013 and August 2015. Median follow-up was 98 months (range 69-101). Median PFS was 7.9 months (95% CI 4.6-10.5). Seven patients (18%) continued afatinib beyond 18 months, 3 beyond 36 months and 2 were still on treatment at last follow-up 101 months post-treatment initiation. Analysis of baseline ctDNA samples identified 8 EGFR mutant cases that were not identified by tissue genotyping and ctDNA clearance was associated with improved PFS and OS.

conclusionAfatinib is a viable treatment option for tissue or ctDNA-detected EGFR mutant NSCLC comorbid patients, with a proportion achieving long-term clinical benefit. Plasma ctDNA testing improved EGFR mutant identification and its clearance predicted improved PFS and OS.

Indexed as

AfatinibCarcinoma, Non-Small-Cell LungCirculating Tumor DNALung NeoplasmsAdultAgedAged, 80 and overErbB ReceptorsFemaleHumansMaleMiddle AgedMutationProtein Kinase InhibitorsAfatinibCirculating Tumor DNAEGFR protein, humanErbB ReceptorsProtein Kinase Inhibitors

Identifiers

PMID39639088
PMCPMC11790930

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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.