SITE014 (NLD)

Sites / NLD

SITE014 (NLD)

NLD · PI Dr. Moreau · activated

KRI 0.438

Patients

19

Active

16

Serious AEs

6

Open QA

2

Aged queries

1

Luna users

0

Studies & contracts

1

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

19

SITE014-0032

enrolled

SITE014-0063

enrolled

SITE014-0082

enrolled

SITE014-0108

completed

SITE014-0113

enrolled

SITE014-0118

completed

SITE014-0125

enrolled

SITE014-0126

enrolled

SITE014-0137

enrolled

SITE014-0141

enrolled

SITE014-0161

enrolled

SITE014-0185

enrolled

SITE014-0197

completed

SITE014-0233

enrolled

SITE014-0253

enrolled

SITE014-0280

enrolled

SITE014-0300

enrolled

SITE014-0311

enrolled

SITE014-0313

enrolled

Safety

52 AEs · 6 serious

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 94); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE014-0185

Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 122); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0125

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 227); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0032

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 61); relationship: not assessed; serious criteria: hospitalization

serious SITE014-0161

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 14); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0197

Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 77); relationship: RELATED; serious criteria: life-threatening

serious SITE014-0125

QA findings

2 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0125, 2026-08-02)

resolved minor

ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject had clinically significant abnormal lab at screening — not excluded (subject SITE014-0253, 2026-07-11)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0125, 2026-06-22)

resolved minor

PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE014-0082, 2026-02-10)

open major

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

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

Open Luna