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Francesco Gelsomino

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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      186TiP - An open-label, randomized phase III study of early switch maintenance vs delayed second-line nivolumab in advanced stage squamous non-small cell lung cancer (NSCLC) patients after standard first-line platinum-based chemotherapy: EDEN trial (ID 569)

      12:30 - 13:00  |  Presenting Author(s): Francesco Gelsomino

      • Abstract


      Squamous non-small cell lung cancer (Sq-NSCLC) represents 20-30% of all NSCLC with a disappointing median overall survival (OS). In the last decades, first-line chemotherapy (Ctx) for advanced Sq-NSCLC has not changed and the standard of care remains a platinum-based regimen (cisplatin or carboplatin) combined with gemcitabine, vinorelbine or taxanes for up to 4-6 cycles. In non-squamous NSCLC, maintenance therapy (MTx) by continuing pemetrexed as single-agent after induction treatment has led to a 3-months improvement in OS. On the contrary, no randomized study has shown a significant benefit from MTx in Sq-NSCLC patients (pts), yet. More recently, nivolumab has become the standard of care as second line therapy. Unfortunately, 30-40% of Sq-NSCLC pts do not have access to second-line therapy because of rapid progression and decline of performance status (PS). Nivolumab as switch MTx would represent a strategy to anticipate its use, allowing more patients to benefit from immune check-points inhibitors.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      Eligible pts: age ≥18, stage IIIB/IV or recurrent Sq-NSCLC, no disease progression (PD) after 4-6 cycles of first-line platinum-based Ctx, ECOG PS ≤ 2, no symptomatic and/or progressive treated brain metastases, good bone marrow, liver and renal functions. 388 pts will be randomized 1:1 to Nivolumab flat dose 240 mg i.v (Arm A) every 2 weeks or best supportive care (BSC) followed by Nivolumab 240 mg i.v at PD (Arm B), and stratified by centre and tumor response to first-line induction Ctx (complete response and partial response vs stable disease). Pts enrolled into Arm A will receive Nivolumab until PD or intolerable toxicity; at PD, they will be treated with Ctx according to local policy. Patients enrolled into Arm B will receive Nivolumab only after radiologic evidence of PD. Nivolumab treatment beyond initial PD will be allowed in both arms. Primary endpoint: OS. Secondary end-points: progression-free survival (PFS), PFS from induction (PFS-ind), time to treatment failure (TTF) and OS from induction (OS-ind). At January 5th 2019, 49 pts were enrolled.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification


      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma, Italy.

      213f68309caaa4ccc14d5f99789640ad Funding


      682889d0a1d3b50267a69346a750433d Disclosure

      L. Cavanna: Personal fees for serving in a consultant and/or advisory role: Astrazeneca, Merck; Honoraria: Celgene, Pfizer, Ipsen. A. Ardizzoni: Research grant support: BMS, Celgene; Personal fees for serving in a consultant and/or advisory role: BMS, MSD, Boehringer Ingelheim; Honoraria: Eli Lilly, Pfizer. All other authors have declared no conflicts of interest.