Site
SITE006 (GBR)
GBR activated KRI 0.444Principal investigator Dr. Rossi
Patients
19
Active
12
enrolled or consented
Withdrawn
2
Serious AEs
13
Open QA findings
1
Aged data queries
0
Studies & contracts
total budget 330000.00 USD
Patients first 19
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE006-0003 | enrolled | 2025-08-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0024 | completed | 2025-09-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0048 | withdrawn | 2025-10-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced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 |
| SITE006-0059 | completed | 2025-11-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0060 | enrolled | 2025-11-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0064 | 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 |
| SITE006-0105 | enrolled | 2026-01-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0123 | completed | 2026-01-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0124 | completed | 2026-01-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0155 | enrolled | 2026-03-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0178 | withdrawn | 2026-03-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0200 | 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 |
| SITE006-0211 | enrolled | 2026-05-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0215 | enrolled | 2026-05-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0230 | completed | 2026-06-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0254 | enrolled | 2026-06-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0258 | enrolled | 2026-07-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0302 | enrolled | 2026-08-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE006-0314 | enrolled | 2026-09-14 | 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
68 AEs · 13 serious
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 53); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-19 (study day 13); relationship: not assessed; serious criteria: hospitalization
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-15 (study day 66); relationship: not assessed; serious criteria: hospitalization
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-20 (study day 40); relationship: NOT RELATED; serious criteria: hospitalization
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-12-10 (study day 30); relationship: not assessed; serious criteria: life-threatening
Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-09-10 (study day 109); relationship: NOT RELATED; serious criteria: life-threatening
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 94); relationship: not assessed; serious criteria: hospitalization
Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-08-06 (study day 3); relationship: not assessed; serious criteria: life-threatening
QA findings
1 open
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE006-0178, 2026-06-16)
MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE006-0211, 2026-06-01)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0178, 2026-05-19)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE006-0105, 2026-05-04)
OTHER: ePRO not completed at scheduled visit (subject SITE006-0105, 2026-02-15)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0024, 2025-10-14)
Monitoring visits 1
Proposed by centralized statistical monitoring (risk score 0.459, composite |z| 1.23): withdrawal rate 11% vs study mean 2%, z=3.01; SAE rate 0.68 vs study mean 0.31, z=2.29; enrollment per open month 1.46 vs study mean 1.71, z=-1.64. Pending CRA confirmation.
Payments 0
No payments on file
Milestone payments are proposed by the finance step and approved in the review queue.