SITE001 (USA)

Sites / USA

SITE001 (USA)

USA · PI Dr. Reyes · activated

KRI 0.174

Patients

21

Active

18

Serious AEs

9

Open QA

1

Aged queries

3

Luna users

4

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

21

SITE001-0026

completed

SITE001-0029

completed

SITE001-0034

enrolled

SITE001-0057

enrolled

SITE001-0066

enrolled

SITE001-0068

enrolled

SITE001-0078

enrolled

SITE001-0092

enrolled

SITE001-0099

enrolled

SITE001-0119

enrolled

SITE001-0134

enrolled

SITE001-0140

enrolled

SITE001-0157

enrolled

SITE001-0165

completed

SITE001-0208

enrolled

SITE001-0216

enrolled

SITE001-0251

enrolled

SITE001-0263

enrolled

SITE001-0267

enrolled

SITE001-0271

enrolled

SITE001-0303

enrolled

Safety

70 AEs · 9 serious

Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning". Solicited symptom report; requires clinical characterization.

serious SITE001-0066

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE001-0119

Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 77); relationship: RELATED; serious criteria: hospitalization

serious SITE001-0216

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 250); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE001-0057

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening

serious SITE001-0092

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 129); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE001-0068

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed; serious criteria: life-threatening

serious SITE001-0165

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization

serious SITE001-0092

QA findings

1 open

MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE001-0119, 2026-09-16)

open major

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE001-0119, 2026-06-15)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE001-0068, 2026-05-21)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0066, 2026-05-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0068, 2026-05-09)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0057, 2026-04-10)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0066, 2026-02-23)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE001-0029, 2025-11-19)

resolved minor

Visits & payments

1

23500 USD

due 2026-10-19

pending_review

Luna participants

4

Maya Okonkwo

SITE001-0034

granted

Jonah Reyes

SITE001-0057

granted

Elif Demir

SITE001-0066

granted

Sam Whitaker

SITE001-0068

pending