SITE006 (GBR)

Sites / GBR

SITE006 (GBR)

GBR · PI Dr. Rossi · activated

KRI 0.444

Patients

19

Active

12

Serious AEs

13

Open QA

1

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

19

SITE006-0003

enrolled

SITE006-0024

completed

SITE006-0048

withdrawn

SITE006-0059

completed

SITE006-0060

enrolled

SITE006-0064

enrolled

SITE006-0105

enrolled

SITE006-0123

completed

SITE006-0124

completed

SITE006-0155

enrolled

SITE006-0178

withdrawn

SITE006-0200

enrolled

SITE006-0211

enrolled

SITE006-0215

enrolled

SITE006-0230

completed

SITE006-0254

enrolled

SITE006-0258

enrolled

SITE006-0302

enrolled

SITE006-0314

enrolled

Safety

68 AEs · 13 serious

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 53); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE006-0258

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 13); relationship: not assessed; serious criteria: hospitalization

serious SITE006-0254

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-15 (study day 66); relationship: not assessed; serious criteria: hospitalization

serious SITE006-0211

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-20 (study day 40); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE006-0211

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-10 (study day 30); relationship: not assessed; serious criteria: life-threatening

serious SITE006-0211

Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-10 (study day 109); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE006-0064

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 94); relationship: not assessed; serious criteria: hospitalization

serious SITE006-0064

Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-06 (study day 3); relationship: not assessed; serious criteria: life-threatening

serious SITE006-0124

QA findings

1 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE006-0178, 2026-06-16)

resolved minor

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE006-0211, 2026-06-01)

open major

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0178, 2026-05-19)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE006-0105, 2026-05-04)

resolved minor

OTHER: ePRO not completed at scheduled visit (subject SITE006-0105, 2026-02-15)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0024, 2025-10-14)

resolved minor

Visits & payments

1

2026-10-03

on_site risk

Luna participants

0

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