SITE007 (JPN)

Sites / JPN

SITE007 (JPN)

JPN · PI Dr. Dubois · activated

KRI 0.252

Patients

19

Active

17

Serious AEs

7

Open QA

1

Aged queries

0

Luna users

0

Studies & contracts

1

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 · 330000 USD

executed

Patients

19

SITE007-0004

enrolled

SITE007-0021

enrolled

SITE007-0033

completed

SITE007-0077

enrolled

SITE007-0085

enrolled

SITE007-0103

completed

SITE007-0122

enrolled

SITE007-0138

enrolled

SITE007-0147

enrolled

SITE007-0151

enrolled

SITE007-0170

enrolled

SITE007-0192

enrolled

SITE007-0217

enrolled

SITE007-0231

enrolled

SITE007-0236

enrolled

SITE007-0250

enrolled

SITE007-0269

enrolled

SITE007-0283

enrolled

SITE007-0298

enrolled

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

serious SITE007-0231

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: RELATED; serious criteria: life-threatening

serious SITE007-0138

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 32); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE007-0250

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 42); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE007-0170

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 60); relationship: not assessed; serious criteria: hospitalization

serious SITE007-0077

Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2022-07-26 (study day 14); relationship: not assessed; serious criteria: life-threatening

serious SITE007-0103

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 3); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE007-0033

QA findings

1 open

MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE007-0077, 2026-09-15)

open major

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE007-0250, 2026-09-11)

resolved minor

Visits & payments

0

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

0

No Luna participants here yet. Participants join once invited by the site.

Open Luna