SITE008 (KOR)

Sites / KOR

SITE008 (KOR)

KOR · PI Dr. Kim · activated

KRI 0.299

Patients

19

Active

17

Serious AEs

5

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

19

SITE008-0022

enrolled

SITE008-0050

completed

SITE008-0052

completed

SITE008-0058

enrolled

SITE008-0065

enrolled

SITE008-0067

enrolled

SITE008-0072

enrolled

SITE008-0133

enrolled

SITE008-0136

enrolled

SITE008-0142

enrolled

SITE008-0159

enrolled

SITE008-0160

enrolled

SITE008-0199

enrolled

SITE008-0201

enrolled

SITE008-0228

enrolled

SITE008-0247

enrolled

SITE008-0276

enrolled

SITE008-0284

enrolled

SITE008-0290

enrolled

Safety

59 AEs · 5 serious

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 261); relationship: not assessed; serious criteria: hospitalization

serious SITE008-0058

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 13); relationship: not assessed; serious criteria: hospitalization

serious SITE008-0247

Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 47); relationship: not assessed; serious criteria: life-threatening

serious SITE008-0199

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 102); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE008-0142

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-09 (study day 75); relationship: not assessed; serious criteria: life-threatening

serious SITE008-0067

QA findings

0 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0133, 2026-08-31)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2026-05-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2026-05-08)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0072, 2026-05-08)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE008-0052, 2026-03-18)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0050, 2026-03-02)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE008-0050, 2026-01-27)

resolved minor

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE008-0052, 2026-01-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0052, 2026-01-14)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0022, 2025-12-11)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE008-0052, 2025-11-30)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0022, 2025-10-19)

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.

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