SITE008 (KOR)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE008-0022 | completed | 2022-03-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0050 | completed | 2022-04-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0052 | completed | 2022-04-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0058 | completed | 2022-05-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0065 | completed | 2022-05-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0067 | completed | 2022-05-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0072 | withdrawn | 2022-05-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0133 | completed | 2022-08-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0136 | completed | 2022-08-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0142 | completed | 2022-08-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0159 | 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 |
| SITE008-0160 | withdrawn | 2022-08-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0199 | completed | 2022-10-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0201 | completed | 2022-10-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0228 | completed | 2022-11-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0247 | completed | 2022-12-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0276 | withdrawn | 2023-01-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0284 | completed | 2023-01-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0290 | completed | 2023-02-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0323 | completed | 2023-03-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0326 | completed | 2023-03-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0358 | 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 |
| SITE008-0386 | completed | 2023-06-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0398 | completed | 2023-06-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0402 | completed | 2023-07-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0408 | withdrawn | 2023-07-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0432 | completed | 2023-08-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0447 | completed | 2023-09-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0448 | completed | 2023-09-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE008-0450 | completed | 2023-09-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 214 AEs · 19 serious
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 261); relationship: not assessed; serious criteria: hospitalization
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-11 (study day 881); relationship: N; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-09 (study day 75); relationship: not assessed; serious criteria: life-threatening
Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 102); relationship: N; serious criteria: hospitalization
Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 47); relationship: not assessed; serious criteria: life-threatening
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 13); relationship: not assessed; serious criteria: hospitalization
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-18 (study day 328); relationship: N; serious criteria: hospitalization
Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 211); relationship: not assessed; serious criteria: hospitalization
QA findings 3 open
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0022, 2022-04-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0022, 2022-06-06)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE008-0022, 2023-07-23)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE008-0050, 2022-07-23)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0050, 2022-08-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2022-11-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2022-11-12)
LATE ASSESSMENT: Safety assessment delayed (subject SITE008-0052, 2022-05-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0052, 2022-07-10)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE008-0052, 2022-07-18)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE008-0052, 2022-09-11)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE008-0065, 2023-08-12)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.