Site
SITE015 (POL)
POL activated KRI 0.308Principal investigator Dr. Ito
Patients
21
Active
15
enrolled or consented
Withdrawn
0
Serious AEs
8
Open QA findings
1
Aged data queries
0
Studies & contracts
total budget 330000.00 USD
Patients first 21
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE015-0002 | completed | 2025-08-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0005 | completed | 2025-08-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0009 | completed | 2025-08-31 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0023 | enrolled | 2025-09-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0030 | enrolled | 2025-09-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0037 | completed | 2025-10-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0044 | enrolled | 2025-10-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0079 | enrolled | 2025-12-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0086 | 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 |
| SITE015-0087 | enrolled | 2025-12-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0102 | completed | 2025-12-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0116 | completed | 2026-01-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0117 | enrolled | 2026-01-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0129 | enrolled | 2026-02-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0148 | enrolled | 2026-02-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0184 | enrolled | 2026-04-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0186 | enrolled | 2026-04-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0198 | enrolled | 2026-04-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0227 | enrolled | 2026-05-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0260 | enrolled | 2026-07-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0308 | enrolled | 2026-09-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants 0
Safety
92 AEs · 8 serious
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 134); relationship: RELATED; serious criteria: life-threatening
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 86); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 226); relationship: RELATED; serious criteria: hospitalization
Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 114); relationship: not assessed; serious criteria: life-threatening
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 162); relationship: not assessed; serious criteria: life-threatening
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-12 (study day 54); relationship: not assessed; serious criteria: hospitalization
Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 56); relationship: not assessed; serious criteria: life-threatening
QA findings
1 open
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0198, 2026-09-13)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE015-0117, 2026-09-05)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0260, 2026-08-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0186, 2026-06-19)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE015-0186, 2026-05-20)
OTHER: Randomisation stratum mis-assigned (subject SITE015-0009, 2026-03-29)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2026-03-15)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0009, 2026-03-06)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0102, 2026-02-23)
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.