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)

Sponsor
AIO-Studien-gGmbH
Study ID
NCT05383001
Phase
PHASE2
Status
Withdrawn

Conditions

  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • combination regimen tremelimumab /durvalumab — DRUG
    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
  • platinum-based chemotherapy (SoC) — DRUG
    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.

Study Details

This is an open label, randomized, Phase II multicenter study designed to evaluate the safety and efficacy of two different second-line strategies: After failure of first line mono-immunotherapy with checkpoint inhibitors (anti-PD-1/PD-L1), and subsequent 2 cycles of standard of care platinum-based chemotherapy, 2 treatment arms will be compared: Arm A (Experimental Arm): After randomization, patients will receive a combination regimen featuring a single, priming dose of tremelimumab together with conventional durvalumab dosing. Durvalumab maintenance therapy will subsequently be continued as study treatment for up to 12 cycles. Arm B: After randomization, patients will continue to receive another 2-4 cycles of platinum-based chemotherapy. Afterwards, patients will end treatment or receive maintenance pemetrexed therapy as per marketing authorization (depending on histology, maximum of 13 cycles) at the discretion of the investigator

Key Dates

Start date
May 20, 2022
Status verified
Sep 2022
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: tremelimumab /durvalumab (1 cycle), subsequently Durvalumab maintenance therapy
  • Other: Arm B: platinum-based chemotherapy (SoC)

Primary Outcome Measure

PFS1 [ Time Frame: 49 months ]

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