SITE013 (USA)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE013-0010 | completed | 2022-02-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0027 | completed | 2022-03-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0028 | completed | 2022-03-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0042 | 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 |
| SITE013-0056 | completed | 2022-04-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0135 | withdrawn | 2022-08-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0173 | 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 |
| SITE013-0174 | withdrawn | 2022-10-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0183 | completed | 2022-10-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0189 | completed | 2022-10-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0196 | completed | 2022-10-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0223 | completed | 2022-11-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0226 | completed | 2022-11-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0232 | completed | 2022-12-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0234 | completed | 2022-11-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0245 | 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 |
| SITE013-0256 | completed | 2022-12-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0257 | completed | 2022-12-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0274 | completed | 2023-01-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0278 | completed | 2023-01-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0285 | completed | 2023-02-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0292 | completed | 2023-02-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0315 | completed | 2023-03-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0348 | completed | 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 |
| SITE013-0356 | completed | 2023-04-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0359 | completed | 2023-04-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0372 | completed | 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 |
| SITE013-0426 | 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 |
| SITE013-0435 | completed | 2023-08-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE013-0440 | completed | 2023-08-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 178 AEs · 18 serious
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 228); relationship: not assessed; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 279); relationship: N; serious criteria: hospitalization
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-21 (study day 40); relationship: N; serious criteria: hospitalization
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 217); relationship: N; serious criteria: hospitalization
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 95); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 32); relationship: not assessed; serious criteria: life-threatening
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 116); relationship: not assessed; serious criteria: hospitalization
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-22 (study day 15); relationship: not assessed; serious criteria: life-threatening
QA findings 5 open
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE013-0028, 2022-07-22)
LATE ASSESSMENT: Safety assessment delayed (subject SITE013-0028, 2022-09-02)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE013-0042, 2022-05-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0042, 2022-06-11)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0056, 2023-03-04)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0174, 2022-10-11)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0174, 2022-11-12)
DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE013-0183, 2023-07-16)
DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE013-0183, 2024-09-09)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Baseline PD-L1 TPS < 50% — eligibility criterion violated (subject SITE013-0189, 2023-05-17)
PROHIBITED CONCOMITANT MEDICATION: Subject received another investigational drug concurrently (subject SITE013-0189, 2023-11-15)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0232, 2023-03-29)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.