SITE015 (POL)

Sites / POL

SITE015 (POL)

POL · PI Dr. Ito · activated

KRI 0.308

Patients

21

Active

15

Serious AEs

8

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

21

SITE015-0002

completed

SITE015-0005

completed

SITE015-0009

completed

SITE015-0023

enrolled

SITE015-0030

enrolled

SITE015-0037

completed

SITE015-0044

enrolled

SITE015-0079

enrolled

SITE015-0086

enrolled

SITE015-0087

enrolled

SITE015-0102

completed

SITE015-0116

completed

SITE015-0117

enrolled

SITE015-0129

enrolled

SITE015-0148

enrolled

SITE015-0184

enrolled

SITE015-0186

enrolled

SITE015-0198

enrolled

SITE015-0227

enrolled

SITE015-0260

enrolled

SITE015-0308

enrolled

Safety

92 AEs · 8 serious

Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-03-06 (study day 134); relationship: RELATED; serious criteria: life-threatening

serious SITE015-0186

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-25 (study day 86); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE015-0227

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization

serious SITE015-0086

Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 226); relationship: RELATED; serious criteria: hospitalization

serious SITE015-0023

Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 114); relationship: not assessed; serious criteria: life-threatening

serious SITE015-0079

Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 162); relationship: not assessed; serious criteria: life-threatening

serious SITE015-0023

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-12 (study day 54); relationship: not assessed; serious criteria: hospitalization

serious SITE015-0037

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 56); relationship: not assessed; serious criteria: life-threatening

serious SITE015-0002

QA findings

1 open

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0198, 2026-09-13)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE015-0117, 2026-09-05)

resolved minor

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0260, 2026-08-27)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0186, 2026-06-19)

resolved minor

OTHER: Pharmacist did not document drug accountability per SOP (subject SITE015-0186, 2026-05-20)

resolved minor

OTHER: Randomisation stratum mis-assigned (subject SITE015-0009, 2026-03-29)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2026-03-15)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0009, 2026-03-06)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0102, 2026-02-23)

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