SITE003 (CAN)

Sites / CAN

SITE003 (CAN)

CAN · PI Dr. Okafor · activated

KRI 0.239

Patients

22

Active

20

Serious AEs

2

Open QA

2

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

22

SITE003-0008

completed

SITE003-0013

enrolled

SITE003-0043

enrolled

SITE003-0051

enrolled

SITE003-0106

completed

SITE003-0109

enrolled

SITE003-0112

enrolled

SITE003-0121

enrolled

SITE003-0130

enrolled

SITE003-0154

enrolled

SITE003-0158

enrolled

SITE003-0163

enrolled

SITE003-0179

enrolled

SITE003-0210

enrolled

SITE003-0222

enrolled

SITE003-0224

enrolled

SITE003-0225

enrolled

SITE003-0242

enrolled

SITE003-0249

enrolled

SITE003-0291

enrolled

SITE003-0293

enrolled

SITE003-0301

enrolled

Safety

61 AEs · 2 serious

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 296); relationship: not assessed; serious criteria: hospitalization

serious SITE003-0013

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 15); relationship: not assessed; serious criteria: life-threatening

serious SITE003-0222

QA findings

2 open

Audit observation: investigational product temperature log has a 3-day gap over a weekend; excursion cannot be excluded for one shipment.

open minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0242, 2026-09-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0291, 2026-09-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE003-0130, 2026-08-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE003-0130, 2026-08-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0222, 2026-07-08)

resolved minor

ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Baseline PD-L1 TPS < 50% — eligibility criterion violated (subject SITE003-0130, 2026-05-28)

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