Evidence map›Paper›PMID 37814061›Full record

Trial reportNature medicine2023

ctDNA response after pembrolizumab in non-small cell lung cancer: phase 2 adaptive trial results.

Valsamo Anagnostou, Cheryl Ho, Garth Nicholas, Rosalyn Anne Juergens, Adrian Sacher, Andrea S Fung, Paul Wheatley-Price, Scott A Laurie, Benjamin Levy, Julie R Brahmer and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04093167 (A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer), which is not on this map. Cited by 122 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 4 pooled it
30.9field-weighted citation impact, top 1% 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.

NCT04093167 phase2 / phase3active not recruitingnot on this map

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

TypeinterventionalSponsorCanadian Cancer Trials GroupRan2020 to 2027Enrolled53ConditionsLung CancerArmsPembrolizumab
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 4 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
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  13. Towards liquid biopsy-based analysis of antitumour immunity.Nature reviews. Clinical oncology · 2026
    Review
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  15. Applications of circulating tumor DNA in unresectable and advanced non-small cell lung cancer immunotherapy: from stratification to therapeutic guidance.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  16. Review
  17. From Tumour to Bloodstream: Advancing PD-L1 Testing With Liquid Biopsies in Non-Small Cell Lung Cancer.Cytopathology : official journal of the British Society for Clinical Cytology · 2026
    Review
  18. Article
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  20. Article

62 more citing papers are in PubMed but not listed here.

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

20 authors at 10 institutions in 2 countries.

Valsamo AnagnostouSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. vanagno1@jhmi.edu.ORCID http://orcid.org/0000-0001-9480-3047
Cheryl HoBCCA-Vancouver Cancer Centre, Vancouver, BC, Canada.
Garth NicholasOttawa Hospital Research Institute, Ottawa, ON, Canada.
Rosalyn Anne JuergensJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON, Canada.
Adrian SacherPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Andrea S FungKingston Health Sciences Centre, Kingston, ON, Canada.
Paul Wheatley-PriceOttawa Hospital Research Institute, Ottawa, ON, Canada.
Scott A LaurieOttawa Hospital Research Institute, Ottawa, ON, Canada.
Benjamin LevySidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Julie R BrahmerSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Archana BalanSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Noushin NiknafsSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Egor AvrutinCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Liting ZhuCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Mark SausenPersonal Genome Diagnostics (LabCorp), Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-2916-5269
Penelope A BradburyPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Jill O'Donnell-TormeyCancer Research Institute, New York, NY, USA.
Pierre Olivier GaudreauCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Keyue DingCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Janet DanceyCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada. jdancey@ctg.queensu.ca.
Queen's University · CAJohns Hopkins University · USOttawa Hospital · CABloomberg (United States) · USUniversity Health Network · CABC Cancer Agency · CACancer Research Institute · USJuravinski Cancer Centre · CAKingston Health Sciences Centre · CALabCorp (United States) · US

Funding

Large-Scale Genetic Analyses of Human CancerR01CA121113 · NCI · JOHNS HOPKINS UNIVERSITY · PI ANAGNOSTOU, VALSAMO, VELCULESCU, VICTOR E. · 2006 to 2022
$4.3M
NCI NIH HHS R01 CA121113NIH HHS CA121113
6 · The paper itself

Abstract

Circulating tumor DNA (ctDNA) has shown promise in capturing primary resistance to immunotherapy. BR.36 is a multi-center, randomized, ctDNA-directed, phase 2 trial of molecular response-adaptive immuno-chemotherapy for patients with lung cancer. In the first of two independent stages, 50 patients with advanced non-small cell lung cancer received pembrolizumab as standard of care. The primary objectives of stage 1 were to ascertain ctDNA response and determine optimal timing and concordance with radiologic Response Evaluation Criteria in Solid Tumors (RECIST) response. Secondary endpoints included the evaluation of time to ctDNA response and correlation with progression-free and overall survival. Maximal mutant allele fraction clearance at the third cycle of pembrolizumab signified molecular response (mR). The trial met its primary endpoint, with a sensitivity of ctDNA response for RECIST response of 82% (90% confidence interval (CI): 52-97%) and a specificity of 75% (90% CI: 56.5-88.5%). Median time to ctDNA response was 2.1 months (90% CI: 1.5-2.6), and patients with mR attained longer progression-free survival (5.03 months versus 2.6 months) and overall survival (not reached versus 7.23 months). These findings are incorporated into the ctDNA-driven interventional molecular response-adaptive second stage of the BR.36 trial in which patients at risk of progression are randomized to treatment intensification or continuation of therapy. ClinicalTrials.gov ID: NCT04093167 .

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedHumansProgression-Free SurvivalAntibodies, Monoclonal, Humanizedpembrolizumab

Identifiers

PMID37814061
PMCPMC10579094
OpenAlexW4387451565

What OpenQuestion holds

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LicenceCC BY
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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.