SITE004 (DEU)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE004-0017 | completed | 2022-03-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0031 | completed | 2022-03-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0041 | completed | 2022-04-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0080 | completed | 2022-05-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0084 | completed | 2022-05-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0088 | completed | 2022-06-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0097 | completed | 2022-06-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0128 | completed | 2022-08-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0144 | withdrawn | 2022-08-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0156 | 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 |
| SITE004-0166 | 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 |
| SITE004-0167 | completed | 2022-09-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0194 | completed | 2022-10-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0220 | 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 |
| SITE004-0229 | completed | 2022-11-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0243 | withdrawn | 2022-12-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0265 | 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 |
| SITE004-0286 | completed | 2023-02-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0288 | completed | 2023-02-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0304 | completed | 2023-02-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0309 | completed | 2023-02-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0325 | completed | 2023-03-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0345 | completed | 2023-04-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0350 | completed | 2023-04-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0360 | completed | 2023-04-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0361 | withdrawn | 2023-04-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0363 | completed | 2023-04-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0375 | completed | 2023-05-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE004-0390 | 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 |
| SITE004-0445 | 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 196 AEs · 18 serious
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 128); relationship: not assessed; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: N; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-28 (study day 367); relationship: N; serious criteria: hospitalization
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 612); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 54); relationship: not assessed; serious criteria: life-threatening
Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 129); relationship: not assessed; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization
QA findings 2 open
MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE004-0041, 2022-05-08)
PROHIBITED CONCOMITANT MEDICATION: Subject received another investigational drug concurrently (subject SITE004-0041, 2023-05-23)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE004-0167, 2023-07-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0220, 2024-01-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0229, 2023-04-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE004-0229, 2024-03-02)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0286, 2023-05-08)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE004-0286, 2023-12-03)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE004-0288, 2024-01-14)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.