SITE007 (JPN)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE007-0004 | 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 |
| SITE007-0021 | completed | 2022-03-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0033 | completed | 2022-03-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0077 | completed | 2022-05-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0085 | completed | 2022-05-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0103 | completed | 2022-07-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0122 | completed | 2022-07-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0138 | 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 |
| SITE007-0147 | completed | 2022-08-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0151 | completed | 2022-08-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0170 | completed | 2022-09-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0192 | completed | 2022-10-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0217 | completed | 2022-11-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0231 | withdrawn | 2022-11-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0236 | completed | 2022-12-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0250 | completed | 2022-12-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0269 | 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 |
| SITE007-0283 | completed | 2023-02-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0298 | completed | 2023-02-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0335 | completed | 2023-04-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0338 | completed | 2023-03-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0340 | completed | 2023-03-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0344 | withdrawn | 2023-04-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0362 | completed | 2023-05-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0378 | withdrawn | 2023-05-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0397 | completed | 2023-07-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0399 | completed | 2023-07-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0405 | completed | 2023-07-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0424 | completed | 2023-08-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0438 | completed | 2023-08-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 196 AEs · 18 serious
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 3); relationship: N; serious criteria: hospitalization
Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 60); relationship: not assessed; serious criteria: hospitalization
Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2022-07-26 (study day 14); relationship: not assessed; serious criteria: life-threatening
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 539); relationship: not assessed; serious criteria: life-threatening
Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: Y; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 475); relationship: not assessed; serious criteria: life-threatening
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 42); relationship: N; serious criteria: hospitalization
Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization
QA findings 2 open
MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE007-0077, 2023-03-11)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE007-0122, 2024-01-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE007-0147, 2023-12-22)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE007-0250, 2023-03-07)
OTHER: ePRO not completed at scheduled visit (subject SITE007-0250, 2023-04-03)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE007-0283, 2024-01-26)
PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE007-0335, 2024-11-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE007-0338, 2023-04-16)
LATE ASSESSMENT: Safety assessment delayed (subject SITE007-0378, 2023-08-03)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE007-0397, 2023-08-13)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE007-0397, 2024-06-28)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE007-0399, 2023-10-05)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.