SITE001 (USA)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE001-0026 | completed | 2022-03-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0029 | completed | 2022-03-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0034 | completed | 2022-04-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0057 | completed | 2022-04-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0066 | completed | 2022-05-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0068 | completed | 2022-05-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0078 | completed | 2022-05-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0092 | completed | 2022-06-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0099 | completed | 2022-06-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0119 | completed | 2022-07-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0134 | completed | 2022-07-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0140 | completed | 2022-08-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0157 | completed | 2022-08-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0165 | completed | 2022-09-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0208 | completed | 2022-10-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0216 | completed | 2022-11-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0251 | 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 |
| SITE001-0263 | completed | 2023-01-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0267 | completed | 2023-01-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0271 | completed | 2023-01-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0303 | completed | 2023-02-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0330 | completed | 2023-03-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0334 | withdrawn | 2023-03-31 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0346 | completed | 2023-04-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0349 | withdrawn | 2023-04-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0366 | completed | 2023-05-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0376 | completed | 2023-05-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0423 | completed | 2023-08-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0427 | completed | 2023-08-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE001-0436 | completed | 2023-09-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 170 AEs · 19 serious
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-11 (study day 12); relationship: not assessed; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 250); relationship: N; serious criteria: hospitalization
Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 129); relationship: N; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 508); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: N; serious criteria: life-threatening
Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-03 (study day 443); relationship: not assessed; serious criteria: hospitalization
QA findings 2 open
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE001-0029, 2022-05-15)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0034, 2023-04-04)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE001-0034, 2023-07-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE001-0034, 2023-10-21)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0057, 2022-10-04)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0066, 2022-08-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0066, 2022-11-12)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE001-0066, 2024-01-24)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0068, 2022-11-02)
LATE ASSESSMENT: Safety assessment delayed (subject SITE001-0068, 2022-11-14)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE001-0068, 2023-04-24)
DOSE MODIFICATION ERROR: Dose held longer than protocol-permitted 6 weeks (subject SITE001-0078, 2024-08-11)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.