SITE014 (NLD)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE014-0032 | completed | 2022-03-31 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0063 | completed | 2022-05-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0082 | completed | 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 |
| SITE014-0108 | completed | 2022-07-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0113 | 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 |
| SITE014-0118 | completed | 2022-07-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0125 | completed | 2022-07-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0126 | completed | 2022-07-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0137 | withdrawn | 2022-08-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced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 |
| SITE014-0141 | completed | 2022-08-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0161 | completed | 2022-09-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0185 | 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 |
| SITE014-0197 | 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 |
| SITE014-0233 | completed | 2022-12-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0253 | completed | 2022-12-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0280 | completed | 2023-01-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0300 | 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 |
| SITE014-0311 | completed | 2023-02-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0313 | completed | 2023-03-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0336 | completed | 2023-04-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0343 | completed | 2023-04-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0374 | 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 |
| SITE014-0385 | completed | 2023-05-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0387 | completed | 2023-06-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0391 | completed | 2023-06-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0417 | completed | 2023-07-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0419 | completed | 2023-08-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0420 | completed | 2023-08-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0431 | completed | 2023-08-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE014-0444 | completed | 2023-09-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 181 AEs · 14 serious
Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 227); relationship: not assessed; serious criteria: life-threatening
Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 77); relationship: Y; serious criteria: life-threatening
Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 122); relationship: not assessed; serious criteria: life-threatening
Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 61); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 94); relationship: N; serious criteria: hospitalization
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 14); relationship: not assessed; serious criteria: life-threatening
Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 68); relationship: not assessed; serious criteria: hospitalization
Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 31); relationship: not assessed; serious criteria: hospitalization
QA findings 3 open
PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE014-0082, 2022-08-06)
MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE014-0082, 2025-01-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0125, 2022-12-16)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0125, 2023-01-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE014-0126, 2023-12-29)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0137, 2024-12-09)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE014-0141, 2023-05-18)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0141, 2023-05-25)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0161, 2023-09-08)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject had clinically significant abnormal lab at screening — not excluded (subject SITE014-0253, 2023-01-04)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0280, 2023-04-23)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0280, 2023-09-07)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.