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Record W4389487695 · doi:10.1016/j.iotech.2023.100587

115TiP MDT-BRIDGE: A phase II study of neoadjuvant durvalumab (D) + chemotherapy (CT) followed by either surgery and adjuvant D or chemoradiotherapy (CRT) and consolidation D in patients (pts) with resectable or borderline resectable stage IIB–IIIB NSCLC

2023· article· en· W4389487695 on OpenAlexaff
Martin Reck, Ernest Nadal, Nicolas Girard, A.R.R. Filippi, L.W. Martin, C.M. Gay, Cordula Petersen, Daniel P. Gale, H.R. Bridge, Naomi Donner, N.E. Georgoulia, Jonathan Spicer

Bibliographic record

VenueImmuno-Oncology Technology · 2023
Typearticle
Languageen
FieldMedicine
TopicMedical Imaging Techniques and Applications
Canadian institutionsMcGill University
FundersGenentechLEO PharmaAptitude HealthEuropean Society for Medical OncologyNovocureRegeneron PharmaceuticalsGilead SciencesIpsenBeiGeneDaiichi Sankyo EuropeSanofiAmgenPfizerLes Laboratories Pierre FabreAstraZenecaEli Lilly and CompanyBristol-Myers Squibb
KeywordsMedicineNeoadjuvant therapyInternal medicineDurvalumabOncologyStage (stratigraphy)ChemotherapyRadiologyCancerImmunotherapyPembrolizumab

Abstract

fetched live from OpenAlex

In the phase 3 AEGEAN study, neoadjuvant D + platinum-based CT followed by adjuvant D, versus neoadjuvant CT alone, significantly improved pathological complete response (pCR) and event-free survival (EFS) in pts with resectable NSCLC. In the placebo-controlled phase 3 PACIFIC study, consolidation D significantly improved outcomes for pts with unresectable stage III NSCLC after CRT. The strong pathological and clinical outcomes seen with CT + immunotherapy (IO) have generated interest in its use to enable pts with borderline resectable NSCLC to undergo surgery (Sx). In parallel, for pts who are initially deemed resectable but later become unresectable/inoperable during neoadjuvant treatment (Tx), the safety and efficacy of initial neoadjuvant IO + CT, followed by CRT and consolidation IO should be explored. To inform clinical practice, MDT-BRIDGE (NCT05925530) assesses the efficacy and safety of neoadjuvant D + CT followed by either Sx and adjuvant D or CRT and consolidation D in pts with resectable/borderline resectable Stage IIB–IIIB NSCLC. This is a global, phase 2, non-randomized study of pts aged ≥18 yr with ECOG PS 0/1 and histologically/cytologically confirmed, Tx-naïve, EGFR/ALK wild-type, Stage IIB to select IIIB [N2] NSCLC (AJCC 8th ed). Initially deemed resectable/borderline resectable by a multidisciplinary team (MDT), ∼140 pts will receive 2 cycles of neoadjuvant D + investigator’s choice platinum-based CT Q3W IV, followed by MDT assessment of resectability. Pts deemed resectable will receive a further 1–2 cycles of neoadjuvant D + CT followed by Sx (Cohort 1); pts deemed unresectable will receive CRT for ∼6 wk (Cohort 2). Pts in Cohort 1 who become ineligible for Sx can enter Cohort 2. After Sx/CRT, all pts will receive D Q4W IV for up to 1 yr. The primary endpoint is the resection rate in all pts. Secondary endpoints include resection rates in the subsets of pts deemed resectable or borderline resectable at baseline; R0, R1, and R2 resection outcomes; pCR; EFS; progression-free survival; overall survival; objective response rate; ctDNA clearance; and safety. NCT05925530 (Release date June 29, 2023). Medical writing support for this abstract, under the direction of the authors, was provided by Werner Gerber, PhD, (Fourways, South Africa) and Aaron Korpal, PhD, (Macclesfield, UK) of Ashfield MedComms, an Inizio Company, and was funded by AstraZeneca. AstraZeneca, Sweden. AstraZeneca.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.401
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0010.002
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.026
GPT teacher head0.355
Teacher spread0.328 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designOther design
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations2
Published2023
Admission routes1
Has abstractyes

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