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.
Resources from the same session
3158 - Tobacco Retail Access and Tobacco Cessation Among Head and Neck Cancer (HNC) Survivors
Presenter: Lawson Eng
Session: Poster Display session 1
Resources:
Abstract
5511 - ASSERT: A Prospective, Observational Study Measuring Sodium Improvement and Outcomes in Patients Treated for Moderate to Severe Hyponatremia Secondary to Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) in Italy (Lung Cancer Cohort)
Presenter: Rossana Berardi
Session: Poster Display session 1
Resources:
Abstract
3821 - Efficacy and safety of controlled ovarian stimulation with or without letrozole co-administration for fertility preservation: A systematic review and meta-analysis.
Presenter: Benedetta Bonardi
Session: Poster Display session 1
Resources:
Abstract
2168 - Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy
Presenter: Tineke Vandenbroucke
Session: Poster Display session 1
Resources:
Abstract
5855 - Update of the registry of young women with cancer by the International Network of Cancer, Infertility and Pregnancy
Presenter: Charlotte Maggen
Session: Poster Display session 1
Resources:
Abstract
5156 - Erectile dysfunction in patients with metastatic renal cell carcinoma
Presenter: Ilya Tsimafeyeu
Session: Poster Display session 1
Resources:
Abstract
4992 - Exercise level, interest and preferences in cancer patients.
Presenter: Alice Avancini
Session: Poster Display session 1
Resources:
Abstract
3427 - Filling the Gaps in Informed Consent for Advanced Cancer Patients considering Phase 1 Oncology Trials - an in-depth Qualitative Study of Key Stakeholders at a large United Kingdom Phase 1 unit
Presenter: Abhijit Pal
Session: Poster Display session 1
Resources:
Abstract
3537 - Breast Cancer Patients’ Quality of Life: Real World Data
Presenter: Thanos Kosmidis
Session: Poster Display session 1
Resources:
Abstract
4761 - High-sensitivity troponin as a cardiotoxicity biomarker in breast cancer treatment
Presenter: Joana Simões
Session: Poster Display session 1
Resources:
Abstract