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U. Weinberg
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P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.08-013 - A Phase II Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma (ID 2337)
09:30 - 09:30 | Author(s): U. Weinberg
- Abstract
Background:
Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, which is based on low intensity alternating electric fields delivered non-invasively using a portable, home use, medical device (NovoTTF-100L, Novocure Ltd.). In-vitro, human mesothelioma cells were found to be highly susceptible to TTFields. When applied to the thorax, TTFields were found to be safe and efficacious in a clinical trial of 42 patients with advanced non-small cell lung cancer, where the only common device-related adverse event was mild to moderate skin reaction. Malignant pleural mesothelioma (MPM) is always fatal when unresectable, and existing therapies provide very limited clinical benefit. Since MPM normally progresses regionally within the thorax, the addition of a regional therapy to systemic chemotherapy is an appealing treatment approach. However, the use of radiation therapy as a loco-regional treatment is limited, due to significant pulmonary toxicity. TTFields may therefore serve as a potential non-toxic regional therapy in MPM.
Methods:
The STELLAR Clinical Trial Eighty (80) patients with unresectable and previously untreated MPM will be treated with pemetrexed and cisplatin or carboplatin in combination with TTFields. The patients will be followed up every 3 weeks (CT scan every 6 weeks) until disease progression. Objectives To test the efficacy and safety of TTFields combined with standard chemotherapy in this patient population. Endpoints The primary endpoint is overall survival (OS) and secondary endpoints are response rate, progression free survival and treatment-emergent toxicity. Statistical Considerations This is a prospective phase II, single arm, multicenter study for 80 patients. The sample size (71 + 12% loss to follow up) is based upon the asymptotic distribution provided by Lachin (2000) using the log of the hazard rate. The historical control is assumed to have an exponential distribution with a constant hazard rate of 0.03938 calculated from the median survival of 12.1 Months reported by Vogelzang et al. The sample size provides 80% power with a two sided alpha of 0.05 to detect an increase of 5.5 months in OS which is equivalent to a Hazard Ratio of 0.67 compared to the historical control data for OS. Major Eligibility Criteria Patients are 18 years of age or older with good performance status (ECOG 0-1). The patients must have pathological or histological evidence of MPM with at least one measurable or evaluable lesion according to modified RECIST criteria. The disease should be previously untreated and not amendable for curative treatment (surgery or radiotherapy). Untreated brain metastases and contraindications to any of the study treatments are exclusionary. Treatment Continuous TTFields at 150 kHz is applied to the thorax using the NovoTTF-100L System. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the thorax using 4 Transducer Arrays. The experimental treatment is administered on top of the standard of care chemotherapy – pemetrexed/platinum doublet.
Results:
not applicable
Conclusion:
not applicable
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-091 - Phase III Study of Front-Line Chemotherapy with TTFields for Advanced Squamous NSCLC (ID 1664)
09:30 - 09:30 | Author(s): U. Weinberg
- Abstract
Background:
Tumor Treating Fields (TTFields) are a novel, non-invasive, anti-mitotic treatment modality, based on low intensity alternating electric fields. TTFields predominantly affect two phases of mitosis: metaphase – by disrupting the formation of the mitotic spindle, and cytokinesis – by dielectrophoretic dislocation of intracellular constituents. Efficacy of TTFields in non-small cell lung cancer (NSCLC) of all histologies has been demonstrated in multiple in vitro and in vivo models, as well as in a phase I/II pilot study, in combination with pemetrexed. At the time of this study, squamous histology patients were still treated with pemetrexed, and those enrolled in the trial surprisingly demonstrated a high median overall survival of 13.8 months. The promising preclinical data, high safety profile and initial clinical data in squamous histology patients have led to the design of the current study.
Methods:
The LUNAR Clinical Trial 300 patients with advanced NSCLC of squamous histology will be randomized in a ratio of 1:1 to receive either standard doublet chemotherapy alone or chemotherapy combined with TTFields. Patients will be followed-up every 6 weeks clinically and radiographically until intra-thoracic progression, then continue a follow up for vital status. Objectives To test the efficacy and safety of TTFields in combination with chemotherapy in this patient population. Endpoints Overall survival (primary), radiological response, progression free survival, in field vs. out of field time to progression, quality of life and safety (secondary). Statistical Considerations This is prospective, randomized, multicenter study for 300 patients. The total sample size of 300 patients (272 + 10% loss to follow up), will achieve a 80% power with an alpha of 0.05 using a two-sided log rank test to detect a hazard ratio of 0.69 for OS. Patients will be stratified based on presence of extra-thoracic disease (intra-thoracic disease only versus extra-thoracic disease), gender (male vs. female) and region. Key Eligibility Criteria Age > 18 years; Intra-thoracic advanced (stage IV) NSCLC with squamous histology; No prior chemotherapy or biological therapy for advanced disease; No prior intra-thoracic radiotherapy for advanced disease; ECOG performance status of 0-1; No serious co-morbidities; No contraindication for chemotherapy or TTFields; Adequate bone marrow, liver and renal functions. Treatment Continuous, daily TTFields Therapy at 150 kHz, applied to the thorax using the NovoTTF-100L System. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the thorax using 4 Transducer Arrays. Chemotherapy options include a taxane or gemcitabine platinum-based doublet.
Results:
not applicable
Conclusion:
not applicable
