SITE003 (CAN)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE003-0008 | completed | 2022-02-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0013 | completed | 2022-02-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0043 | completed | 2022-04-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0051 | withdrawn | 2022-05-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0106 | completed | 2022-07-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0109 | completed | 2022-06-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0112 | completed | 2022-07-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0121 | completed | 2022-07-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0130 | completed | 2022-08-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0154 | completed | 2022-09-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0158 | completed | 2022-09-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0163 | completed | 2022-09-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0179 | completed | 2022-09-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0210 | completed | 2022-11-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0222 | completed | 2022-11-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0224 | completed | 2022-11-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0225 | completed | 2022-11-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0242 | completed | 2022-12-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0249 | completed | 2022-12-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0291 | completed | 2023-02-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0293 | completed | 2023-02-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0301 | completed | 2023-02-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0329 | completed | 2023-04-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0368 | completed | 2023-05-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0384 | completed | 2023-05-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0393 | completed | 2023-06-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0403 | completed | 2023-07-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0406 | withdrawn | 2023-07-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0407 | completed | 2023-07-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE003-0434 | completed | 2023-08-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 198 AEs · 17 serious
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 296); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 224); relationship: N; serious criteria: life-threatening
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 416); relationship: N; serious criteria: hospitalization
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 554); relationship: N; serious criteria: life-threatening
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 133); relationship: N; serious criteria: life-threatening
Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 15); relationship: not assessed; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-03 (study day 315); relationship: not assessed; serious criteria: hospitalization
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-09-18 (study day 574); relationship: not assessed; serious criteria: life-threatening
QA findings 2 open
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE003-0112, 2023-04-29)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Baseline PD-L1 TPS < 50% — eligibility criterion violated (subject SITE003-0130, 2022-11-21)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE003-0130, 2023-01-31)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE003-0130, 2023-01-31)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0130, 2023-12-06)
OTHER: Wrong study drug dispensed at site (corrected next cycle) (subject SITE003-0210, 2024-01-07)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0222, 2023-01-01)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE003-0222, 2023-06-03)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE003-0222, 2023-07-06)
LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE003-0222, 2023-11-05)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE003-0222, 2024-01-21)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0224, 2024-04-04)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.