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L. Horn
Moderator of
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Non-small cell neuro-endocrine tumours (ID 32)
- Event: ELCC 2018
- Type: Educational session
- Track:
- Presentations: 4
- Now Available
- Moderators:A. Dingemans, L. Horn
- Coordinates: 4/14/2018, 11:20 - 12:50, Room A
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Diagnosis and pathology classification (Now Available) (ID 128)
11:20 - 11:40 | Presenting Author(s): A.G. Nicholson
- Abstract
- Presentation
Abstract not provided
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Non-surgical treatment of carcinoids (Now Available) (ID 131)
12:20 - 12:40 | Presenting Author(s): A. Lamarca
- Abstract
- Presentation
Abstract not provided
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Staging and surgical treatment of carcinoids (ID 130)
12:00 - 12:20 | Presenting Author(s): M. García-Yuste
- Abstract
Abstract not provided
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Treatment of large cell neuro-endocrine carcinoma (Now Available) (ID 129)
11:40 - 12:00 | Presenting Author(s): A. Dingemans
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
Author of
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New perspectives in the treatment of SCLC (ID 31)
- Event: ELCC 2018
- Type: Educational session
- Track:
- Presentations: 1
- Now Available
- Moderators:M. O'Brien, F. Mornex
- Coordinates: 4/14/2018, 09:20 - 10:50, Room A
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The current role of immunotherapy and its place in the future (Now Available) (ID 126)
10:20 - 10:40 | Presenting Author(s): L. Horn
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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194TiP - eXalt3: Phase 3 randomized study comparing ensartinib to crizotinib in anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients (ID 644)
12:50 - 12:50 | Presenting Author(s): L. Horn
- Abstract
Background:
Ensartinib (X-396) is a novel, potent ALK small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naïve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of ensartinib appears to be different than other ALK TKIs.
Trial design:
In this global, phase 3, open-label, randomized study, approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized with stratification by prior chemotherapy (0/1), performance status (0 − 1/2), brain metastases at screening (absence/presence), and geographic region (Asia/other), to receive oral ensartinib (225 mg, once daily) or crizotinib (250 mg, twice daily) until disease progression or intolerable toxicity.Eligibility also includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤ 2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The primary endpoint is progression-free survival assessed by independent radiology review based on RECIST v. 1.1 criteria. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. The study has > 80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05.Phase 3 recruitment began in June, 2016 and currently has 98 active sites in 20 countries. The duration of recruitment will be approximately 24 months.
Clinical trial identification:
NCT02767804
Legal entity responsible for the study:
Xcovery Holding Corporation
Funding:
Betta Pharmaceuticals
Disclosure:
L. Horn: Consulting for Xcovery Holding Company, BMS, BI, Abbvie, Genentech, Merck. Y-L. Wu: Speaker fees from AstraZeneca, Roche, Eli Lily. M. Reck: Honoraria for lectures and consultancy: Hoffman-La Roche, Lily, BMS, MSD, AstraZeneca, Merck, Celgene, Boehringer-Ingelheim, Pfizer, Novartis. C. Liang, K. Harrow, V. Oertel, G. Dukart: Full-Time Employee: Xcovery Holding Corporation, F. Tan: Manager: Xcovery Holding Company Chief Medical Officer: Betta Pharmaceuticals. T.S.K. Mok: Grant/Research Support from AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai, Taiho; Speaker's fees with: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Novartis, BMS, Taiho; Major Stock Shareholder in: Sanomics Ltd.; Advisory Board for: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Clovis Oncology, Merck Serono, MSD, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, BMS, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc.; Board of Directors: IASLC, Chinese Lung Cancer Research Foundation Ltd., Chinese Society of Clinical Oncology (CSCO), Hong Kong Cancer Therapy Society (HKCTS).
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197TiP - A phase 1/2 trial of selinexor combined with docetaxel for previously treated, advanced KRAS mutant non-small cell lung cancer (ID 244)
12:50 - 12:50 | Author(s): L. Horn
- Abstract
Background:
Selinexor is an oral, reversible inhibitor of exportin-1 (XPO1), the major nuclear export protein responsible for nucleocytoplasmic transport of multiple tumor suppressor proteins and cell cycle regulators. Upregulation of XPO1 results in tumorigenesis and inactivation of apoptosis. Pharmacologic targeting of this process, termed selective inhibition of nuclear export (SINE), has demonstrated anti-tumor efficacy in preclinical and clinical trials. The most extensively studied SINE to date, selinexor (KPT-330; Karyopharm Therapeutics, Inc., Newton, MA), has demonstrated single-agent anticancer activity and synergistic effects in combination regimens against multiple cancer types. SINE may have particular relevance in KRAS-driven tumors, for which this treatment strategy demonstrates significant synthetic lethality. Thus, we designed a phase 1/2 study to assess the safety and tolerability of selinexor in combination with docetaxel in patients with previously treated, advanced KRAS mutant non-small cell lung cancer (NSCLC).
Trial design:
This is a multicenter, single-arm, open-label, non-blinded trial. Eligible patients are aged ≥18 years with advanced NSCLC and by central testing documenting presence of KRAS mutation (codons 12, 13, or 61). We will enroll 9–18 patients in the dose escalation cohort and 35 patients in the expansion cohort at five institutions with UT Southwestern as the primary coordinating center for this study. Dose escalation will be performed in a traditional 3 + 3 design. Patients will receive selinexor orally once weekly, with a lead in period of 1 week before chemotherapy initiation, in combination with standard doses of docetaxel given once every 3 weeks. Treatment will be administered in 21-day cycles. Dose limiting toxicities will be assessed based on the first cycle (7-day lead-in + 21-day cycle = 28 day) toxicity. The primary objective is to determine the safety and the maximum tolerated dose and recommended Phase 2 dose of selinexor administered with the standard dose of docetaxel. The sample size estimate is based on the exact one-sample binomial test for proportions. Enrollment will open in January 2018.
Clinical trial identification:
NCT03095612
Legal entity responsible for the study:
University of Texas Southwestern Medical Center, Dallas, TX, USA
Funding:
Karyopharm Therapeutics, Inc., Newton, MA
Disclosure:
L. Horn: Has consulting for Abbvie, Astra Zeneca, Lilly, BMS, Merck, Roche-Genentech, Xcovery. D.E. Gerber: Research funding from Karyopharm. All other authors have declared no conflicts of interest.
