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 — 178 AEs, 18 serious
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-11-18 (study day 228); relationship: not assessed; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 279); relationship: N; serious criteria: hospitalization
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-21 (study day 40); relationship: N; serious criteria: hospitalization
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-12-15 (study day 217); relationship: N; serious criteria: hospitalization
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 95); relationship: not assessed; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-11-02 (study day 32); relationship: not assessed; serious criteria: life-threatening
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-25 (study day 116); relationship: not assessed; serious criteria: hospitalization
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-22 (study day 15); relationship: not assessed; serious criteria: life-threatening
QA findings (5 open)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE013-0028, 2022-07-22)
LATE ASSESSMENT: Safety assessment delayed (subject SITE013-0028, 2022-09-02)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE013-0042, 2022-05-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0042, 2022-06-11)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0056, 2023-03-04)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0174, 2022-10-11)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE013-0174, 2022-11-12)
DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE013-0183, 2023-07-16)
DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE013-0183, 2024-09-09)
ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Baseline PD-L1 TPS < 50% — eligibility criterion violated (subject SITE013-0189, 2023-05-17)
PROHIBITED CONCOMITANT MEDICATION: Subject received another investigational drug concurrently (subject SITE013-0189, 2023-11-15)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE013-0232, 2023-03-29)
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