Randomized Phase II, Open-label Efficacy and Safety Study of Second-line Durvalumab Plus Tremelimumab Versus Platinum-based Chemotherapy Alone in Patients With NSCLC and First-line Checkpoint-inhibitor Therapy (Re-Check)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 20, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
NSCLC Stage IV
Interventions
DRUG

combination regimen tremelimumab /durvalumab

"Induction treatment: 2 cyles of Q3W second-line plantium-based chemotherapy according to standard of care: Cisplatin or carboplatin in combination with pemetrexed, paclitaxel, nab-paclitaxel, vinorelbine or gemcitabine~Combination treatment:~Durvalumab 1500 mg fixed dose plus tremelimumab 300 mg fixed bolus dose~Maintenance Therapy:~Durvalumab 1500 mg fixed dose Q4W up to 12 cycles within the study"

DRUG

platinum-based chemotherapy (SoC)

"Induction treatment: 2 cyles of Q3W second-line plantium-based chemotherapy according to standard of care: Cisplatin or carboplatin in combination with pemetrexed, paclitaxel, nab-paclitaxel, vinorelbine or gemcitabine~Combination treatment:~Continuation of second-line chemotherapy with 2-4 further cycles (Q3W) platinum-based combination therapy.~Maintenance Therapy:~Optional continued maintenance therapy with pemetrexed according to marketing authorization will be allowed for a maximum of 13 cycles."

Trial Locations (1)

82131

Asklepios Fachkliniken München-Gauting, Gauting

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER