Site
SITE009 (AUS)
AUS activated KRI 0.387Principal investigator Dr. Novak
Patients
20
Active
19
enrolled or consented
Withdrawn
0
Serious AEs
2
Open QA findings
2
Aged data queries
0
Studies & contracts
total budget 330000.00 USD
Patients first 20
| Ref | Status | Consented | Study |
|---|---|---|---|
| SITE009-0016 | enrolled | 2025-09-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0036 | enrolled | 2025-10-17 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0040 | enrolled | 2025-10-11 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0055 | enrolled | 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 |
| SITE009-0070 | enrolled | 2025-11-26 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0073 | enrolled | 2025-11-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0081 | enrolled | 2025-12-05 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0089 | enrolled | 2025-12-21 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0091 | enrolled | 2025-12-20 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0098 | enrolled | 2025-12-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0120 | enrolled | 2026-01-23 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0143 | enrolled | 2026-02-14 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0145 | enrolled | 2026-02-10 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0162 | enrolled | 2026-03-22 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0168 | enrolled | 2026-03-25 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0182 | enrolled | 2026-03-30 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0191 | enrolled | 2026-04-19 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0255 | enrolled | 2026-06-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0259 | completed | 2026-07-09 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
| SITE009-0268 | enrolled | 2026-07-24 | A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer |
Luna participants 0
Safety
66 AEs · 2 serious
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 204); relationship: not assessed; serious criteria: life-threatening
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-25 (study day 29); relationship: not assessed; serious criteria: hospitalization
QA findings
2 open
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE009-0268, 2026-08-13)
OTHER: Randomisation stratum mis-assigned (subject SITE009-0036, 2026-06-07)
LATE ASSESSMENT: Safety assessment delayed (subject SITE009-0182, 2026-05-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE009-0168, 2026-04-29)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE009-0145, 2026-03-06)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE009-0016, 2025-11-16)
Monitoring visits 1
Proposed by centralized statistical monitoring (risk score 0.399, composite |z| 1.02): lab flags per patient 24.05 vs study mean 16.95, z=2.64. Pending CRA confirmation.
Payments 0
No payments on file
Milestone payments are proposed by the finance step and approved in the review queue.