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News
Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial
23+ hour, 45+ min ago (401+ words) The Clinical Trial Vanguard Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial Topotecan has been the default second-line chemotherapy for relapsed small-cell lung cancer for decades, and its survival benefit in that setting is modest…...
Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC
23+ hour, 43+ min ago (362+ words) clinicaltrialvanguard.com Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC Three dose levels entered a randomized expansion cohort; only one came out with a Phase 3 ticket. SystImmune and Bristol Myers Squibb will present at WCLC in Seoul on…...
Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study
3+ day, 23+ hour ago (344+ words) The Clinical Trial Vanguard Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study Sixty milligrams once daily: that is the dose Tyra Biosciences selected from SURF302 after the Phase 2 study returned its first results on September 9, and the choice carries real…...
Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock
3+ day, 23+ hour ago (386+ words) The Clinical Trial Vanguard Seismic Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Istaroxime for Cardiogenic Shock Cardiogenic shock kills roughly half the patients it reaches in the ICU, a mortality burden that has persisted for decades without a single…...
Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease
4+ day, 23+ hour ago (336+ words) The Clinical Trial Vanguard Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease A $50 million check is the clearest signal yet that Novartis believes VAV1 degradation works in humans. Monte Rosa Therapeutics triggered that milestone payment on September 8, 2026, when Novartis…...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
4+ day, 22+ hour ago (790+ words) The Clinical Trial Vanguard A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue A clinical operations lead gets the news from her biostatistics team: the new digitally enhanced composite endpoint just cut the required sample…...
Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata
4+ day, 23+ hour ago (323+ words) The Clinical Trial Vanguard Nektar to Release 24-Week Off-Treatment Data for Rezpegaldesleukin in Alopecia Areata Nektar Therapeutics went quiet on September 8, 2026, and will stay that way until it releases the 24-week off-treatment follow-up data from its Phase 2b REZOLVE-AA study of…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
1+ week, 23+ hour ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...
Early Termination No Longer Means Failure. It Means the Trial Was Working.
1+ week, 1+ day ago (616+ words) The Clinical Trial Vanguard Early Termination No Longer Means Failure. It Means the Trial Was Working. The CheckMate 057 trial was supposed to run longer. Bristol Myers Squibb had enrolled hundreds of patients with non-small cell lung cancer, randomized them between…...
AI Agents in Clinical Trials Require Human Review Before Data Commits
1+ week, 1+ day ago (423+ words) The Clinical Trial Vanguard AI Agents in Clinical Trials Require Human Review Before Data Commits A phase 3 protocol in 2020 collected an average of 3.56 million data points. By 2025 that number had climbed to 5.96 million, a 67% rise in five years and more…...