GalenOps prod · 0.1.0

Patients

21

Active

18

enrolled or consented

Withdrawn

0

Serious AEs

7

Open QA findings

1

Aged data queries

0

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 21

RefStatusConsentedStudy
SITE004-0017 enrolled 2025-09-07 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0031 completed 2025-10-01 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0041 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
SITE004-0080 enrolled 2025-12-01 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0084 completed 2025-12-01 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0088 enrolled 2025-12-13 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0097 enrolled 2025-12-18 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0128 completed 2026-02-05 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0144 enrolled 2026-02-20 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0156 enrolled 2026-03-03 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0166 enrolled 2026-03-12 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0167 enrolled 2026-03-16 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0194 enrolled 2026-04-21 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0220 enrolled 2026-05-22 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0229 enrolled 2026-05-29 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0243 enrolled 2026-06-13 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0265 enrolled 2026-07-20 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0286 enrolled 2026-08-12 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0288 enrolled 2026-08-14 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0304 enrolled 2026-09-04 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer
SITE004-0309 enrolled 2026-09-02 A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

Luna participants 0

No Luna participants yet

Participants at this site have not been invited to Luna.

Safety

77 AEs · 7 serious

serious SITE004-0156 assessed

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0156 assessed

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 129); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0194 assessed

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 3); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0128 assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 54); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0017 assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 128); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0088 assessed

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0031 assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: NOT RELATED; serious criteria: life-threatening

QA findings

1 open

open major Protocol deviation

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE004-0041, 2025-11-12)

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.