Evidence map›Paper›PMID 39904561›Full record

Trial reportJournal for immunotherapy of cancer2025

Perioperative pembrolizumab in early-stage non-small cell lung cancer (NSCLC): safety, efficacy, and exploratory biomarker analysis.

Cameron Wood, Liliana Lyniv, James M Isaacs, Jacob M Kaufman, Eziafa I Oduah, Jeff Clarke, Jeffrey Crawford, Thomas Stinchcombe, Betty C Tong, Xiaofei Wang and 6 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
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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

16 authors.

Cameron WoodMedical Oncology, Bon Secours Richmond Health System, Kilmarnock, Virginia, USA.ORCID http://orcid.org/0009-0008-0336-0411
Liliana LynivDivision of Medical Oncology, Duke University Health System, Durham, North Carolina, USA.
James M IsaacsDivision of Hematology Oncology, Cleveland Clinic, Cleveland, Ohio, USA.
Jacob M KaufmanDivision of Medical Oncology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Eziafa I OduahDivision of Medical Oncology, Duke University Health System, Durham, North Carolina, USA.
Jeff ClarkeDivision of Medical Oncology, Duke University Health System, Durham, North Carolina, USA.
Jeffrey CrawfordDivision of Medical Oncology, Duke University Health System, Durham, North Carolina, USA.
Thomas StinchcombeDivision of Medical Oncology, Duke University Health System, Durham, North Carolina, USA.
Betty C TongDivision of Cardiovascular and Thoracic Surgery, Duke University Health System, Durham, North Carolina, USA.
Xiaofei WangDuke Cancer Institute Biostatistics, Duke University School of Medicine, Durham, North Carolina, USA.
Lin GuDuke Cancer Institute Biostatistics, Duke University School of Medicine, Durham, North Carolina, USA.
Dennis WigleDepartment of Thoracic Surgery, Mayo Clinic, Rochester, Minnesota, USA.
Konstantin H DragnevDivision of Hematology-Oncology, Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, New Hampshire, USA.
Scott J AntoniaMedical Oncology, Duke University Medical Center, Durham, North Carolina, USA.
Kent WeinholdDepartment of Surgery, Duke University Health System, Durham, North Carolina, USA.
Neal ReadyMedical Oncology, Duke University Medical Center, Durham, North Carolina, USA neal.ready@duke.edu.ORCID http://orcid.org/0000-0003-4414-9432

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOur study was designed to determine the safety, efficacy, and immunological effects of perioperative pembrolizumab in early-stage NSCLC.

methodsThis is a single-arm phase II study of perioperative pembrolizumab in patients with untreated, clinical stage IB to IIIA NSCLC. Patients received two doses of 200 mg pembrolizumab, surgery, standard adjuvant chemotherapy, followed by four doses adjuvant pembrolizumab. The primary objective of this study was to determine surgical feasibility rate, and secondary objectives are pathological response rate, treatment adverse events, efficacy data, and exploratory analysis of biomarkers.

results30 patients initiated perioperative pembrolizumab, and 25 completed tumor resection. At median follow-up of 59 months after surgical resection, seven patients had disease progression, while six had died representing. A 5-year progression-free survival (PFS) from time of surgery was 72.0% (56.4%-91.9%) and overall survival (OS) from time of surgery was 75.8% (60.7%-94.7%). Major pathological response (MPR) was found in seven tumors (28%) including two complete responses (4%). Across all treated patients, four receiving neoadjuvant and four receiving adjuvant pembrolizumab experienced treatment-related adverse events of grade 3 or higher with no grade 5 events. Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) levels increased across our patient cohort over time from baseline until postsurgery and remained elevated at the end of treatment. There was a significant difference between mean plasma PCSK9 levels for patients with MPR versus all other patients on study when checked postoperatively.

conclusionsPerioperative pembrolizumab was safe and effective with promising MPR rate, PFS, and OS.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedNeoplasm StagingTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorpembrolizumabBiomarkerImmune Checkpoint InhibitorImmunotherapyLung CancerPathologic complete response - pCR

Identifiers

PMID39904561
PMCPMC11795402

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.