Site
SITE001 (USA)
USA activated KRI 0.174Principal investigator Dr. Reyes
Patients
21
Active
18
enrolled or consented
Withdrawn
0
Serious AEs
9
Open QA findings
1
Aged data queries
3
Studies & contracts
total budget 330000.00 USD
Patients first 21
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE001-0026 | completed | 2025-09-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0029 | completed | 2025-09-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0034 | enrolled | 2025-10-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0057 | enrolled | 2025-10-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0066 | enrolled | 2025-11-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0068 | enrolled | 2025-11-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0078 | enrolled | 2025-12-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0092 | enrolled | 2025-12-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0099 | enrolled | 2025-12-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0119 | enrolled | 2026-01-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0134 | enrolled | 2026-01-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0140 | enrolled | 2026-02-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0157 | enrolled | 2026-03-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0165 | completed | 2026-03-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0208 | enrolled | 2026-05-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0216 | enrolled | 2026-05-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0251 | enrolled | 2026-06-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0263 | enrolled | 2026-07-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0267 | enrolled | 2026-07-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0271 | enrolled | 2026-07-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0303 | enrolled | 2026-08-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants 4
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.
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: NOT RELATED; serious criteria: life-threatening
Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 77); relationship: RELATED; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 250); relationship: NOT RELATED; serious criteria: hospitalization
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening
Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 129); relationship: NOT RELATED; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-02 (study day 7); relationship: not assessed; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization
QA findings
1 open
MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE001-0119, 2026-09-16)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE001-0119, 2026-06-15)
LATE ASSESSMENT: Safety assessment delayed (subject SITE001-0068, 2026-05-21)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0066, 2026-05-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0068, 2026-05-09)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0057, 2026-04-10)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0066, 2026-02-23)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE001-0029, 2025-11-19)
Monitoring visits 0
No visits recorded
Re-score risk to propose an on-site visit.