SITE005 (FRA)

Sites / FRA

SITE005 (FRA)

FRA · PI Dr. Muller · activated

KRI 0.328

Patients

21

Active

17

Serious AEs

8

Open QA

0

Aged queries

0

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

21

SITE005-0001

enrolled

SITE005-0014

withdrawn

SITE005-0020

enrolled

SITE005-0045

completed

SITE005-0047

enrolled

SITE005-0074

enrolled

SITE005-0090

enrolled

SITE005-0104

enrolled

SITE005-0131

completed

SITE005-0139

enrolled

SITE005-0150

completed

SITE005-0212

enrolled

SITE005-0219

enrolled

SITE005-0240

enrolled

SITE005-0246

enrolled

SITE005-0262

enrolled

SITE005-0273

enrolled

SITE005-0287

enrolled

SITE005-0305

enrolled

SITE005-0307

enrolled

SITE005-0317

enrolled

Safety

65 AEs · 8 serious

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 30); relationship: not assessed; serious criteria: hospitalization

serious SITE005-0273

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-02 (study day 21); relationship: RELATED; serious criteria: hospitalization

serious SITE005-0262

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 11); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE005-0150

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 40); relationship: not assessed; serious criteria: hospitalization

serious SITE005-0104

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-05 (study day 62); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE005-0047

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 33); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE005-0047

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-05 (study day 80); relationship: not assessed; serious criteria: life-threatening

serious SITE005-0014

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 72); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE005-0014

QA findings

0 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0212, 2026-09-05)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0287, 2026-08-25)

resolved minor

OTHER: ePRO not completed at scheduled visit (subject SITE005-0131, 2026-05-29)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE005-0001, 2026-03-11)

resolved minor

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