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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)

NCT05383001 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-27

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Niels Reinmuth, Prof. Dr. · Asklepios Fachkliniken München-Gauting, Thorakale Onkologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383001 on ClinicalTrials.gov