Sites / ITA

SITE011 (ITA)

ITA · PI Dr. Jansen · activated

KRI 0.306

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

SITE011-0007

SITE011-0011

SITE011-0035

SITE011-0038

SITE011-0049

SITE011-0075

SITE011-0083

SITE011-0107

SITE011-0114

SITE011-0115

SITE011-0146

SITE011-0175

SITE011-0176

SITE011-0177

SITE011-0204

SITE011-0218

SITE011-0239

SITE011-0261

SITE011-0281

SITE011-0289

SITE011-0297

SITE011-0299

SITE011-0310

SITE011-0316

Safety

80 AEs · 5 serious

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 81); relationship: not assessed; serious criteria: hospitalization

serious SITE011-0239

Grade 4 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 44); relationship: not assessed; serious criteria: life-threatening

serious SITE011-0239

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 59); relationship: RELATED; serious criteria: life-threatening

serious SITE011-0107

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-20 (study day 34); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE011-0107

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-29 (study day 12); relationship: not assessed; serious criteria: hospitalization

serious SITE011-0107

QA findings

2 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0239, 2026-09-16)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0204, 2026-09-02)

resolved minor

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE011-0035, 2026-07-23)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0175, 2026-07-17)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0038, 2026-06-23)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0075, 2026-06-22)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE011-0038, 2026-03-30)

resolved minor

DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE011-0114, 2026-03-16)

open major

Visits & payments

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

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