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 — 196 AEs, 18 serious
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 128); relationship: not assessed; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: N; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-04-28 (study day 367); relationship: N; serious criteria: hospitalization
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-02-07 (study day 612); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 54); relationship: not assessed; serious criteria: life-threatening
Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 129); relationship: not assessed; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization
QA findings (2 open)
MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE004-0041, 2022-05-08)
PROHIBITED CONCOMITANT MEDICATION: Subject received another investigational drug concurrently (subject SITE004-0041, 2023-05-23)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE004-0167, 2023-07-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0220, 2024-01-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0229, 2023-04-26)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE004-0229, 2024-03-02)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE004-0286, 2023-05-08)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE004-0286, 2023-12-03)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE004-0288, 2024-01-14)
Visits & payments
Nothing scheduled.
☾ Luna participants
No Luna participants here yet.