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Poster Display session 1

5997 - Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer (SCLC): The PAVE study, a Hellenic Cooperative Oncology Group Study

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Small Cell Lung Cancer

Presenters

Helena Linardou

Citation

Annals of Oncology (2019) 30 (suppl_5): v710-v717. 10.1093/annonc/mdz264

Authors

H. Linardou1, G. Mountzios2, A. Psyrri3, A. Christopoulou4, K. Sakellariou1, H. Vaja5, A. Grivas6, T. Makatsoris7, G. Aravantinos8, E. Samantas9

Author affiliations

  • 1 Oncology Unit, Metropolitan Hospital, 185 47 - Athens/GR
  • 2 2nd Department Of Medical Oncology, Henry Dunant Hospital Center, 154 51 - Athens/GR
  • 3 Internal Medicine/medical Oncology, Attikon University Hospital, 12462 - Athens/GR
  • 4 Medical Oncology, Agios Andreas General Hospital of Patras, 11524 - Athens/GR
  • 5 Oncology, Attikon University Hospital, 12462 - Athens/GR
  • 6 Oncology, Hellenic Cooperative Oncology Group, 11524 - Athens/GR
  • 7 Oncology, University Hospital Patras, 265 00 - Patras/GR
  • 8 Head,2nd Department Of Medical Oncology, General Oncological Hospital of Kifisia "Agioi Anargyroi", 14564 - Kifisia/GR
  • 9 Oncology, General Oncological Hospital of Kifisia "Agioi Anargyroi", 14564 - Kifisia/GR

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Abstract 5997

Background

Advanced small cell lung cancer (SCLC) remains a disease with dismal prognosis and new therapeutics are urgently needed.

SCLC is notably chemosensitive and first-line chemotherapy with platinum analogs and etoposide is associated with high rates of initial objective responses that unfortunately do not last long.

This initial tumor shrinkage provokes neoantigen release in the circulation, sometimes clinically expressed as “tumor lysis syndrome”, rendering thus the disease potently immunogenic.

We hypothesized that initial chemotherapy with two cycles of cisplatin-etoposide may trigger tumor lysis and subsequent release of neo-antigens that may in turn enhance immune responses against tumor cells with the addition of an anti-PD-L1 monoclonal antibody, such as avelumab.

Trial design

PAVE (Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer) is a Greek, investigator- initiated, single arm open- label phase II study of Avelumab in combination with cisplatin or carboplatin/ etoposide. The study will include an initial safety run-in, open-label, single arm part (Part 1), and the actual phase II study (Part 2). The total number of patients will not change (the safety run-in patients will be included in the final total number of participants). The safety run-in period will not alter the total study timelines, as phase II accrual will follow immediately after the safety run-in. Eligible patients will receive: The standard 1st-line therapy for advanced small cell lung cancer, consisting of: Cisplatin 80 mg/m2 or Carboplatin 5 AUC D1 q three weeks for 4-6 cycles Etoposide 100 mg/m2 D1-D3 every three weeks for 4-6 cycles and Avelumab 10 mg/kg q 2 weeks will be given as a 1 hour intravenous infusion (IV) every two weeks starting from the third chemotherapy cycle until chemotherapy completion and as maintenance treatment every two weeks (q 2 weeks) thereafter until disease progression.

Clinical trial identification

PAVE study (HE1/17) Identifier: NCT03568097.

Editorial acknowledgement

Legal entity responsible for the study

Hellenic Cooperative Oncology Group (HeCOG).

Funding

Merck KGaA.

Disclosure

All authors have declared no conflicts of interest.

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