Site
SITE012 (BRA)
BRA activated KRI 0.384Principal investigator Dr. Kowalski
Patients
26
Active
21
enrolled or consented
Withdrawn
0
Serious AEs
7
Open QA findings
2
Aged data queries
1
Studies & contracts
total budget 330000.00 USD
Patients first 26
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE012-0006 | enrolled | 2025-08-29 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0012 | enrolled | 2025-09-03 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0015 | completed | 2025-09-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0019 | enrolled | 2025-09-08 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0053 | completed | 2025-11-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0061 | enrolled | 2025-11-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0076 | enrolled | 2025-11-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0093 | enrolled | 2025-12-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0096 | enrolled | 2026-01-01 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0100 | completed | 2025-12-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0110 | enrolled | 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 |
| SITE012-0149 | enrolled | 2026-03-04 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0164 | enrolled | 2026-03-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0169 | enrolled | 2026-03-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0172 | enrolled | 2026-03-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0195 | enrolled | 2026-04-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0203 | enrolled | 2026-04-27 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0213 | completed | 2026-05-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0252 | enrolled | 2026-06-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0264 | enrolled | 2026-07-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0266 | enrolled | 2026-07-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0272 | enrolled | 2026-07-18 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0277 | completed | 2026-08-02 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0282 | enrolled | 2026-08-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0306 | enrolled | 2026-08-28 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE012-0312 | enrolled | 2026-09-06 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants 0
Safety
81 AEs · 7 serious
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 114); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 336); relationship: not assessed; serious criteria: hospitalization
Grade 3 Asthenia — outcome: UNKNOWN; onset 2022-12-31 (study day 60); relationship: not assessed; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 22); relationship: not assessed; serious criteria: hospitalization
Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-20 (study day 94); relationship: NOT RELATED; serious criteria: life-threatening
Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 2); relationship: NOT RELATED; serious criteria: hospitalization
Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 39); relationship: not assessed; serious criteria: hospitalization
QA findings
2 open
LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE012-0169, 2026-08-30)
PROHIBITED CONCOMITANT MEDICATION: Subject received systemic corticosteroid > 10 mg/d prednisone equivalent (subject SITE012-0277, 2026-08-17)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE012-0093, 2026-08-04)
LATE ASSESSMENT: Safety assessment delayed (subject SITE012-0110, 2026-07-05)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE012-0213, 2026-07-03)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE012-0169, 2026-04-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE012-0015, 2026-02-23)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE012-0053, 2025-12-15)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE012-0053, 2025-12-10)
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.