SITE013 (USA)

Sites / USA

SITE013 (USA)

USA · PI Dr. Clarke · activated

KRI 0.467

Patients

23

Active

20

Serious AEs

13

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

23

SITE013-0010

enrolled

SITE013-0027

enrolled

SITE013-0028

completed

SITE013-0042

completed

SITE013-0056

enrolled

SITE013-0135

enrolled

SITE013-0173

enrolled

SITE013-0174

withdrawn

SITE013-0183

enrolled

SITE013-0189

enrolled

SITE013-0196

enrolled

SITE013-0223

enrolled

SITE013-0226

enrolled

SITE013-0232

enrolled

SITE013-0234

enrolled

SITE013-0245

enrolled

SITE013-0256

enrolled

SITE013-0257

enrolled

SITE013-0274

enrolled

SITE013-0278

enrolled

SITE013-0285

enrolled

SITE013-0292

enrolled

SITE013-0315

enrolled

Safety

75 AEs · 13 serious

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 13); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE013-0278

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 23); relationship: not assessed; serious criteria: hospitalization

serious SITE013-0257

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 116); relationship: not assessed; serious criteria: hospitalization

serious SITE013-0173

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 48); relationship: not assessed; serious criteria: life-threatening

serious SITE013-0226

Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-14 (study day 35); relationship: not assessed; serious criteria: hospitalization

serious SITE013-0232

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 279); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE013-0027

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 217); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE013-0056

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 228); relationship: not assessed; serious criteria: hospitalization

serious SITE013-0027

QA findings

0 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0056, 2026-09-08)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE013-0278, 2026-09-08)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0174, 2026-05-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0174, 2026-04-17)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE013-0028, 2026-03-09)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE013-0028, 2026-01-26)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0042, 2025-12-16)

resolved minor

OTHER: Pharmacist did not document drug accountability per SOP (subject SITE013-0042, 2025-12-01)

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