Sites / AUS

SITE009 (AUS)

AUS · PI Dr. Novak · activated

KRI 0.387

Patients

Active

Serious AEs

Open QA

Aged queries

Luna users

Studies & contracts

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

Phase III · study active · 330000 USD

executed

Patients

SITE009-0016

SITE009-0036

SITE009-0040

SITE009-0055

SITE009-0070

SITE009-0073

SITE009-0081

SITE009-0089

SITE009-0091

SITE009-0098

SITE009-0120

SITE009-0143

SITE009-0145

SITE009-0162

SITE009-0168

SITE009-0182

SITE009-0191

SITE009-0255

SITE009-0259

SITE009-0268

Safety

66 AEs · 2 serious

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 204); relationship: not assessed; serious criteria: life-threatening

serious SITE009-0016

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-25 (study day 29); relationship: not assessed; serious criteria: hospitalization

serious SITE009-0040

QA findings

2 open

PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE009-0268, 2026-08-13)

open major

OTHER: Randomisation stratum mis-assigned (subject SITE009-0036, 2026-06-07)

open major

LATE ASSESSMENT: Safety assessment delayed (subject SITE009-0182, 2026-05-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE009-0168, 2026-04-29)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE009-0145, 2026-03-06)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE009-0016, 2025-11-16)

resolved minor

Visits & payments

2026-10-03

on_site risk

Luna participants

No Luna participants here yet. Participants join once invited by the site.

Open Luna