○ Evidence tier 3 — Human open-label pilot (feasibility / biomarker)

Record verify: verified against primary source

DesignFirst-in-human open-label pilot
N14
RegistryNCT02874989
PMID30616998
DOI10.1016/j.ebiom.2018.12.052
Citation statuspmid+doi verified via PubMed eutils (EBioMedicine 2019;40:554-563; PMC6412088); NCT02874989 from websearch

Identifiers: DOI verified; PMC verified; PMID verified; trial registry id verified. Record-level verification and identifier-level status are separate: a record can be fully verified against its primary publication while an identifier that cannot apply to the study type — a trial registry ID for an animal study, for instance — is marked not applicable. No identifier is fabricated, and none is left in a “pending” state.

Not the same study

This record is the 2019 first-in-human open-label pilot (Justice et al., EBioMedicine 2019;40:554-563; PMID 30616998), which had no control group. A separate, later publication reports a single-blind randomized placebo-controlled pilot in the same indication (Nambiar et al., EBioMedicine 2023;90:104481; PMID 36857968, n=12). The two share the registry identifier NCT02874989, so the registry number alone does not distinguish them. They must not be merged: the physical-function improvement reported here was uncontrolled, and the later controlled pilot did not find a meaningful difference between the treatment and placebo groups.

Five-qualifier claim

Species / populationAdults with idiopathic pulmonary fibrosis (n=14), two-centre open-label pilot.
Exposure, route, scheduleOral dasatinib 100 mg/day + quercetin 1250 mg/day, 3 days/week over 3 weeks (intermittent).
Comparator / durationSingle-arm, open-label; no control group and no blinding. Approximately 3-week intermittent intervention with short follow-up.
Endpoint / numeric resultPrimary endpoints were feasibility (retention/completion); most consistent secondary improvement was in physical function/mobility measures (e.g. 6-minute walk, gait speed, chair-stands).
What it did NOT establishNot powered for efficacy; no control group, so the observed physical-function improvement cannot be attributed to the drug. No lung-function disease-modification claim; no lifespan outcome.