SITE015 (POL)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE015-0002 | completed | 2022-02-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0005 | completed | 2022-02-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0009 | completed | 2022-02-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0023 | completed | 2022-03-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0030 | completed | 2022-03-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0037 | completed | 2022-04-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0044 | completed | 2022-04-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0079 | 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 |
| SITE015-0086 | completed | 2022-05-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0087 | completed | 2022-06-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0102 | completed | 2022-06-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0116 | completed | 2022-07-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0117 | completed | 2022-07-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0129 | completed | 2022-07-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0148 | 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 |
| SITE015-0184 | completed | 2022-10-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0186 | 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 |
| SITE015-0198 | 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 |
| SITE015-0227 | completed | 2022-11-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0260 | completed | 2022-12-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0308 | completed | 2023-03-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0322 | 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 |
| SITE015-0369 | 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 |
| SITE015-0379 | completed | 2023-05-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0388 | completed | 2023-06-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0404 | completed | 2023-07-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0418 | completed | 2023-08-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0422 | withdrawn | 2023-07-31 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE015-0425 | 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 |
| SITE015-0443 | completed | 2023-09-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 188 AEs · 17 serious
Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 56); relationship: not assessed; serious criteria: life-threatening
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 162); relationship: not assessed; serious criteria: life-threatening
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 226); relationship: Y; serious criteria: hospitalization
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-12 (study day 54); relationship: not assessed; serious criteria: hospitalization
Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 114); relationship: not assessed; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 359); relationship: not assessed; serious criteria: hospitalization
Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-03-04 (study day 627); relationship: N; serious criteria: life-threatening
QA findings 6 open
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0009, 2022-08-30)
OTHER: Randomisation stratum mis-assigned (subject SITE015-0009, 2022-09-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0102, 2022-08-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2022-09-08)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE015-0117, 2023-03-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2023-06-20)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE015-0148, 2023-04-28)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE015-0186, 2022-11-13)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0186, 2022-12-13)
MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE015-0186, 2023-05-05)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE015-0186, 2023-05-23)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0198, 2023-03-09)
Monitoring visits (1)
Proposed by risk-based monitoring (score 0.77). Pending CRA confirmation.
Payments (0)
No payments on file.