Lume-meso: A double-blind, randomized, phase II/III study of nintedanib (N) + pemetrexed (P)/cisplatin (C) followed by maintenance N versus placebo + P/C followed by maintenance placebo for patients with unresectable malignant pleural mesothelioma (MPM).
Bibliographic record
Abstract
TPS8574 Background: Median overall survival (OS) is ~1 year with P/C, the standard front-line treatment for patients (pts) with unresectable MPM; additional improvement is needed. Nintedanib (N) is an oral, twice-daily, triple angiokinase inhibitor of VEGF, PDGF and FGF as well as Src and Abl kinase signalling, all of which are involved in regulating tumor angiogenesis, growth, and metastasis of MPM. Inhibition of the VEGF pathway has been validated as a treatment approach for MPM (J Clin Oncol 2015;33:A7500). Nintedanib (VARGATEF) in combination with docetaxel is approved in the European Union and other countries for locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma histology after first-line chemotherapy and has shown clinical benefit in trials in several tumor types. The current study was extended from a Phase II to a confirmatory Phase II/III trial after all Phase II pts had enrolled. Methods: Chemo-naive pts from 25 countries ( ≥ 18 years of age, ECOG PS 0–1, and histologically confirmed epithelioid/biphasic MPM; 87 pts in Phase II/310‒450 pts in Phase III) will be randomized (1:1) to receive up to 6 cycles of P (500 mg/m2)/C (75 mg/m2) on Day 1 plus N (200 mg bid) or placebo from Days 2–21. Pts without disease progression (PD) will continue to receive maintenance treatment with N or placebo until PD. The primary endpoint is progression-free survival (PFS); OS is the key secondary endpoint. The study will use an adaptive design strategy, with sample size reassessment by an external DMC based on interim analysis to ensure sufficient power for PFS/OS. Additional secondary endpoints include objective tumor response and disease control according to modified RECIST. Other assessments include frequency/severity of adverse events, laboratory parameters, change in forced vital capacity, health-related quality-of-life and exploratory predictive biomarker analyses in tumor/blood specimens. The study is currently enrolling pts into Phase III. Clinical trial information: NCT01907100.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.009 | 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".