Studies & contracts
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 completed · contract executed · 330000 USD
Patients (30)
Safety — 181 AEs, 14 serious
Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-22 (study day 227); relationship: not assessed; serious criteria: life-threatening
Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-10-20 (study day 77); relationship: Y; serious criteria: life-threatening
Grade 4 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-12-04 (study day 122); relationship: not assessed; serious criteria: life-threatening
Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-11-21 (study day 61); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-01-24 (study day 94); relationship: N; serious criteria: hospitalization
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 14); relationship: not assessed; serious criteria: life-threatening
Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-19 (study day 68); relationship: not assessed; serious criteria: hospitalization
Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-04-18 (study day 31); relationship: not assessed; serious criteria: hospitalization
QA findings (3 open)
PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE014-0082, 2022-08-06)
MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE014-0082, 2025-01-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0125, 2022-12-16)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0125, 2023-01-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE014-0126, 2023-12-29)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0137, 2024-12-09)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE014-0141, 2023-05-18)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0141, 2023-05-25)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE014-0161, 2023-09-08)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject had clinically significant abnormal lab at screening — not excluded (subject SITE014-0253, 2023-01-04)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0280, 2023-04-23)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE014-0280, 2023-09-07)
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