Abstract 1417TiP
Background
Traditionally, patients with stage IV non-small cell lung carcinoma (NSCLC) were considered palliative without curative potential. Recent data suggest that oligometastatic patients can be treated with curative intent, using combined modality local ablative therapy (surgery and/or radiotherapy (RT)) and systemic therapy. Stereotactic Body Radiation Therapy (SBRT) allows treatment of NSCLC primaries with diameter ≤5 cm and metastases at virtually all anatomical locations with increased overall and progression-free survival and little side effects. Minimally invasive surgery for early and locally advanced NSCLC achieves excellent local tumour control with promising survival data at low rate of complications. Immune-checkpoint inhibitors (ICIs) have substantially improved outcome in metastatic NSCLC and has become first-line treatment in non-driver mutated disease, alone or combined with chemotherapy (CT). SBRT has been proposed to enhance the efficacy of ICIs. CHESS builds on encouraging data to combine systemic treatment with ICIs, SBRT and surgery.
Trial design
CHESS is a single-arm, multicentre phase II trial evaluating the efficacy of ICIs, CT, RT and/or surgery in oligometastatic NSCLC. Treatment consists of durvalumab (1500 mg i.v.) combined with 4-6 cycles of platinum-based doublet CT and SBRT to all oligo-metastatic lesions. For patients that have not progressed at the 3-month 18FDG-PET/CT restaging, treatment will be completed with radical resection or definitive RT of the primary cancer. Total 47 patients from Switzerland, the Netherlands and Spain will be recruited. Eligible patients have confirmed NSCLC with maximum three distant metastases, one of which must be extra-cerebral. Patients with activating driver mutations or patients that have received prior line of treatment are excluded. Primary endpoint is progression-free survival at 12 months. Safety is closely monitored by the ETOP IDMC. CHESS is sponsored and coordinated by ETOP with financial support by AstraZeneca. Accrual is ongoing and as of 20 May 2020, five patients have been enrolled.
Clinical trial identification
NCT03762018.
Editorial acknowledgement
Legal entity responsible for the study
European Thoracic Oncology Platform (ETOP).
Funding
AstraZeneca.
Disclosure
M. Guckenberger: Research grant/Funding (self), research support: Varian; Research grant/Funding (self), research support: AstraZeneca. A. Curioni Fontecedro: Honoraria (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): Takeda; Honoraria (self): MSD. A. Scherz: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Takeda. O. Elicin: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy: MSD. A. Addeo: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche. J.G.J.V. Aerts: Honoraria (self): Merck Sharp & Dohme; Honoraria (self): BMS; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Amphera; Honoraria (self): Eli Lilly; Honoraria (self): Takeda; Honoraria (self): Bayer; Honoraria (self): Roche. L. Hendriks: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, interview sessions funded by Roche: Roche; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution), mentorship program with key opinion leaders: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Takeda; Speaker Bureau/Expert testimony: MSD; Honoraria (self): Quadia. O. Juan-Vidal: Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Takeda. I. Sullivan: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony: AstraZeneca. J. Valdivia: Honoraria (self), Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (self), Travel/Accommodation/Expenses: Eisai; Honoraria (self), Travel/Accommodation/Expenses: AstraZeneca. S. Peters: Advisory/Consultancy: AbbVie; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Biocartis; Advisory/Consultancy: Bioinvent; Advisory/Consultancy: Blueprint Medicines; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: Boehringer Ingelheim; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: BMS; Advisory/Consultancy, Research grant/Funding (institution): Clovis; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Debiopharm; Advisory/Consultancy, Talk in a company’s organized public event: Eli Lilly; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: Roche; Advisory/Consultancy: Foundation Medicine; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: Illumina; Advisory/Consultancy: Janssen; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: MSD; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono; Advisory/Consultancy: Merrimack; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: Novartis; Advisory/Consultancy: PharmaMar; Advisory/Consultancy, Research grant/Funding (institution), Talk in a company’s organized public event: Pfizer; Advisory/Consultancy: Regeneron; Advisory/Consultancy, Talk in a company’s organized public event: Sanofi; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy, Talk in a company’s organized public event: Takeda; Advisory/Consultancy: Vaccibody; Research grant/Funding (institution): Biocesix. R.A. Stahel: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (self), Honoraria (institution), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Regeneron; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Honoraria (institution), Speaker Bureau/Expert testimony: Boehringer Ingelheim; Honoraria (self), Speaker Bureau/Expert testimony: Eli Lilly; Honoraria (institution): BMS; Honoraria (institution): Genentech. All other authors have declared no conflicts of interest.