SITE010 (ESP)
Studies & contracts total budget 330000.00 USD
Patients first 30
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE010-0039 | completed | 2022-04-07 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0046 | withdrawn | 2022-04-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0094 | completed | 2022-06-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0095 | completed | 2022-06-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0101 | completed | 2022-06-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0111 | completed | 2022-07-13 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0127 | completed | 2022-07-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0152 | completed | 2022-08-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0181 | completed | 2022-09-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0190 | completed | 2022-10-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0205 | completed | 2022-10-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0206 | completed | 2022-10-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0207 | completed | 2022-11-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0221 | 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 |
| SITE010-0238 | 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 |
| SITE010-0248 | 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 |
| SITE010-0275 | completed | 2023-01-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0279 | completed | 2023-01-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0294 | completed | 2023-02-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0296 | completed | 2023-02-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0318 | completed | 2023-03-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0319 | completed | 2023-03-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0377 | withdrawn | 2023-05-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0381 | completed | 2023-05-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0395 | completed | 2023-06-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0411 | withdrawn | 2023-07-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0429 | completed | 2023-08-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0441 | completed | 2023-09-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE010-0446 | 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 |
| SITE010-0449 | completed | 2023-09-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants (0)
No participants at this site use Luna yet.
Safety 194 AEs · 10 serious
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 64); relationship: N; serious criteria: life-threatening
Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-05-10 (study day 577); relationship: Y; serious criteria: life-threatening
Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 195); relationship: N; serious criteria: hospitalization
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 5); relationship: not assessed; serious criteria: hospitalization
Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-02 (study day 8); relationship: Y; serious criteria: life-threatening
Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-25 (study day 440); relationship: not assessed; serious criteria: life-threatening
Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 53); relationship: N; serious criteria: life-threatening
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 125); relationship: not assessed; serious criteria: hospitalization
QA findings 3 open
MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE010-0039, 2022-10-09)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject enrolled despite failing inclusion criterion 4 (ECOG PS) (subject SITE010-0039, 2023-03-16)
LATE ASSESSMENT: Safety assessment delayed (subject SITE010-0046, 2024-12-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0094, 2022-09-25)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0094, 2022-11-29)
LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE010-0094, 2022-12-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0101, 2023-01-21)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE010-0111, 2023-02-12)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0111, 2023-03-28)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE010-0127, 2022-10-13)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0127, 2023-02-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE010-0127, 2023-07-03)
Monitoring visits (0)
No visits recorded.
Payments (0)
No payments on file.