Abstract 1667TiP
Background
Small cell lung cancer (SCLC) represents approximately 13% of all newly diagnosed lung cancers. Most patients have extensive-stage (ES) disease at diagnosis, and prognosis remains poor, with a 5-year survival less than 2% despite receiving the standard of care: four to six cycles of etoposide (ET) in combination with either cisplatin (CPT) or carboplatin (CP) (platinum (PT) –etoposide). CASPIAN trial showed that durvalumab (D) in combination with PT-ET in treatment-naive patients with ES-SCLC improved overall survival. However, there is limited information in patients with ECOG PS 2, specific comorbidities, controlled autoimmune diseases, or in patients where the investigator can expect benefit from a prophylactic cranial irradiation. Therefore, there remains an unmet need for additional data in the use of D plus PT-ET as first-line treatment for unselected patients in real clinical practice. This study will assess safety and effectiveness of D plus PT-ET in a real-world ES-SCLC population. Immune and biological characteristics of populations during the study, quality of life and health care resources use will be evaluated.
Trial design
This phase IIIb, interventional, single arm, multicentre study has included 102 patients from 35 participating sites in Spain. Eligible patients were ≥18 years with treatment naive ES-SCLC, ECOG PS 0-2, eligible to receive PT based therapy, at least one lesion suitable for repeated measurements as per RECIST 1.1 criteria, with life expectancy of at least 12 weeks and adequate organ function. Patients with brain metastases were eligible provided they were asymptomatic or had been treated at least 2 weeks prior to study treatment and were receiving 10 mg/day or less of prednisone or equivalent. Patients who had received chemoradiotherapy for Localized-Stage SCLC and have experienced a treatment-free interval of at least 6 months were eligible. D (1500 mg) will be concurrently administered with first-line CPT or CP d1 plus ET d1-3 on an every 3 week schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week schedule until confirmed progressive disease or unacceptable toxicity.
Clinical trial identification
EudraCT 2020-002328-35; NCT04712903.
Editorial acknowledgement
Juan Luis Sanz (APICES) for the editorial assistance in the writing of the abstract.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
L. Paz-Ares: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Advisory Board: Mirati; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Tesaro; Financial Interests, Personal, Member of the Board of Directors: Altum Sequencing; Financial Interests, Institutional, Principal Investigator: Alkermes; Financial Interests, Personal, Principal Investigator: Amgen; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Daiichi Sankyo; Financial Interests, Institutional, Principal Investigator: IO Biotech; Financial Interests, Institutional, Principal Investigator: Janssen Cilag International Nv; Financial Interests, Institutional, Principal Investigator: Lilly; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: PharmaMar; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Sanofi; Financial Interests, Institutional, Principal Investigator: Takeda; Financial Interests, Institutional, Principal Investigator: Tesaro. E. Arriola: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker: Roche; Financial Interests, Personal and Institutional, Advisory Board: Roche; Financial Interests, Personal and Institutional, Research Grant: Roche; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS. M.R. Garcia Campelo: Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Advisory Role: MSD; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Advisory Role: Lilly; Financial Interests, Institutional, Advisory Board: Takeda; Financial Interests, Institutional, Invited Speaker: Takeda; Financial Interests, Institutional, Advisory Role: Takeda; Financial Interests, Institutional, Advisory Board: Janssen; Financial Interests, Institutional, Invited Speaker: Janssen; Financial Interests, Institutional, Advisory Role: Janssen; Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Advisory Role: Amgen; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Role: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Role: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Advisory Role: Novartis. M.P. Diz Tain: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Invited Speaker: Amgen. M.C. Marti Blanco: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca. L. Leon-Mateos: Non-Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Non-Financial Interests, Personal and Institutional, Principal Investigator: Lilly; Non-Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Non-Financial Interests, Personal, Advisory Board: Amgen; Non-Financial Interests, Personal and Institutional, Principal Investigator: Roche; Non-Financial Interests, Personal and Institutional, Principal Investigator: MSD; Non-Financial Interests, Personal, Advisory Board: AstraZeneca. A. Sanchez Hernandez: Financial Interests, Personal and Institutional, Invited Speaker: Roche; Financial Interests, Personal and Institutional, Advisory Board: Roche; Financial Interests, Personal and Institutional, Principal Investigator: Roche; Financial Interests, Personal and Institutional, Invited Speaker: MSD; Financial Interests, Personal and Institutional, Advisory Board: MSD; Financial Interests, Personal and Institutional, Invited Speaker: Janssen; Financial Interests, Personal and Institutional, Advisory Board: Janssen; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker: Amgen; Financial Interests, Personal and Institutional, Advisory Board: Amgen; Financial Interests, Personal and Institutional, Invited Speaker: Novartis; Financial Interests, Personal and Institutional, Advisory Board: Novartis; Financial Interests, Personal and Institutional, Invited Speaker: BMS; Financial Interests, Personal and Institutional, Advisory Board: BMS; Financial Interests, Personal and Institutional, Invited Speaker: Sanofi; Financial Interests, Personal and Institutional, Advisory Board: Sanofi; Financial Interests, Personal and Institutional, Invited Speaker: Pfizer; Financial Interests, Personal and Institutional, Advisory Board: Pfizer. J.M. Oramas Rodriguez: Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: BMS. M. Majem: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Tesaro; Financial Interests, Personal, Advisory Role: Helsinn Therapeutics; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Institutional, Funding, Research Funding. BMS; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Lilly. C. Aguado de la Rosa: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal and Institutional, Advisory Board: Pierre Fabre; Financial Interests, Personal, Principal Investigator: Mirati; Financial Interests, Personal, Advisory Board: BMS. R. Alvarez Cabellos: Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Board: Pfizer. Á. Callejo Mellén: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. L. Baez: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. D. Isla: Non-Financial Interests, Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Institutional, Advisory Board: AstraZeneca. All other authors have declared no conflicts of interest.