Site
SITE007 (JPN)
JPN activated KRI 0.252Principal investigator Dr. Dubois
Patients
19
Active
17
enrolled or consented
Withdrawn
0
Serious AEs
7
Open QA findings
1
Aged data queries
0
Studies & contracts
total budget 330000.00 USD
Patients first 19
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE007-0004 | enrolled | 2025-08-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0021 | enrolled | 2025-09-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0033 | completed | 2025-09-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0077 | enrolled | 2025-11-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0085 | enrolled | 2025-12-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0103 | completed | 2026-01-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0122 | enrolled | 2026-01-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0138 | enrolled | 2026-02-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0147 | enrolled | 2026-02-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0151 | enrolled | 2026-02-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0170 | enrolled | 2026-03-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0192 | enrolled | 2026-04-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0217 | enrolled | 2026-05-16 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0231 | enrolled | 2026-05-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0236 | enrolled | 2026-06-12 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0250 | enrolled | 2026-06-15 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0269 | enrolled | 2026-07-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0283 | enrolled | 2026-08-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE007-0298 | enrolled | 2026-08-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants 0
Safety
71 AEs · 7 serious
Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization
Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: RELATED; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 32); relationship: NOT RELATED; serious criteria: life-threatening
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 42); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 60); relationship: not assessed; serious criteria: hospitalization
Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2022-07-26 (study day 14); relationship: not assessed; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 3); relationship: NOT RELATED; serious criteria: hospitalization
QA findings
1 open
MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE007-0077, 2026-09-15)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE007-0250, 2026-09-11)
Monitoring visits 0
No visits recorded
Re-score risk to propose an on-site visit.
Payments 0
No payments on file
Milestone payments are proposed by the finance step and approved in the review queue.