Site
SITE013 (USA)
USA activated KRI 0.467Principal investigator Dr. Clarke
Patients
23
Active
20
enrolled or consented
Withdrawn
1
Serious AEs
13
Open QA findings
0
Aged data queries
0
Studies & contracts
total budget 330000.00 USD
Patients first 23
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE013-0010 | enrolled | 2025-09-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0027 | enrolled | 2025-09-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0028 | completed | 2025-09-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0042 | completed | 2025-10-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0056 | enrolled | 2025-10-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0135 | enrolled | 2026-02-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0173 | enrolled | 2026-03-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0174 | withdrawn | 2026-04-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0183 | enrolled | 2026-04-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0189 | enrolled | 2026-04-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0196 | enrolled | 2026-04-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0223 | enrolled | 2026-05-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0226 | enrolled | 2026-06-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0232 | enrolled | 2026-06-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0234 | enrolled | 2026-06-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0245 | enrolled | 2026-06-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0256 | enrolled | 2026-07-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0257 | enrolled | 2026-06-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0274 | enrolled | 2026-07-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0278 | enrolled | 2026-08-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0285 | enrolled | 2026-08-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0292 | enrolled | 2026-08-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0315 | enrolled | 2026-09-08 | 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 0
Safety
75 AEs · 13 serious
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-02-23 (study day 13); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 23); relationship: not assessed; serious criteria: hospitalization
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 116); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-17 (study day 48); relationship: not assessed; serious criteria: life-threatening
Grade 3 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2023-01-14 (study day 35); relationship: not assessed; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 279); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 217); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 228); relationship: not assessed; serious criteria: hospitalization
QA findings
0 open
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0056, 2026-09-08)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE013-0278, 2026-09-08)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0174, 2026-05-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0174, 2026-04-17)
LATE ASSESSMENT: Safety assessment delayed (subject SITE013-0028, 2026-03-09)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE013-0028, 2026-01-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0042, 2025-12-16)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE013-0042, 2025-12-01)
Monitoring visits 0
No visits recorded
Re-score risk to propose an on-site visit.
Payments 0
No payments on file
Milestone payments are proposed by the finance step and approved in the review queue.