GalenOps prod · 0.1.0

Patients

19

Active

16

enrolled or consented

Withdrawn

0

Serious AEs

6

Open QA findings

2

Aged data queries

1

Studies & contracts

total budget 330000.00 USD

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
Phase III study active contract executed 330000 USD

Patients first 19

RefStatusConsentedStudy
SITE014-0032 enrolled 2025-10-05 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0063 enrolled 2025-11-08 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0082 enrolled 2025-11-29 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0108 completed 2026-01-09 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0113 enrolled 2026-01-12 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0118 completed 2026-01-16 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0125 enrolled 2026-01-27 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0126 enrolled 2026-01-27 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0137 enrolled 2026-02-13 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0141 enrolled 2026-02-17 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0161 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
SITE014-0185 enrolled 2026-04-13 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0197 completed 2026-04-24 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0233 enrolled 2026-06-08 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0253 enrolled 2026-06-21 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0280 enrolled 2026-08-03 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0300 enrolled 2026-08-23 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0311 enrolled 2026-09-03 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE014-0313 enrolled 2026-09-15 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Safety

52 AEs · 6 serious

serious SITE014-0185 assessed

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 94); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE014-0125 assessed

Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 122); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0032 assessed

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 227); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0161 assessed

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 61); relationship: not assessed; serious criteria: hospitalization

serious SITE014-0197 assessed

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 14); relationship: not assessed; serious criteria: life-threatening

serious SITE014-0125 assessed

Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 77); relationship: RELATED; serious criteria: life-threatening

QA findings

2 open

resolved minor Protocol deviation

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0125, 2026-08-02)

open major Protocol deviation

ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject had clinically significant abnormal lab at screening — not excluded (subject SITE014-0253, 2026-07-11)

resolved minor Protocol deviation

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0125, 2026-06-22)

open major Protocol deviation

PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE014-0082, 2026-02-10)

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.