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
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".