SITE010 (ESP)

Sites / ESP

SITE010 (ESP)

ESP · PI Dr. Silva · activated

KRI 0.381

Patients

20

Active

16

Serious AEs

3

Open QA

2

Aged queries

1

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

20

SITE010-0039

enrolled

SITE010-0046

enrolled

SITE010-0094

completed

SITE010-0095

completed

SITE010-0101

enrolled

SITE010-0111

enrolled

SITE010-0127

enrolled

SITE010-0152

enrolled

SITE010-0181

enrolled

SITE010-0190

enrolled

SITE010-0205

enrolled

SITE010-0206

completed

SITE010-0207

enrolled

SITE010-0221

completed

SITE010-0238

enrolled

SITE010-0248

enrolled

SITE010-0275

enrolled

SITE010-0279

enrolled

SITE010-0294

enrolled

SITE010-0296

enrolled

Safety

62 AEs · 3 serious

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-02 (study day 8); relationship: RELATED; serious criteria: life-threatening

serious SITE010-0248

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 5); relationship: not assessed; serious criteria: hospitalization

serious SITE010-0206

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 64); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE010-0095

QA findings

2 open

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0127, 2026-08-29)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0238, 2026-08-25)

resolved minor

PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE010-0111, 2026-08-19)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0101, 2026-07-28)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE010-0094, 2026-06-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0094, 2026-06-05)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE010-0127, 2026-04-19)

resolved minor

MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE010-0039, 2026-04-15)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0094, 2026-04-01)

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