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Sam Janes
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P1.11 - Screening and Early Detection (ID 177)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.11-19 - Trial in Progress: Cancer Screening Study With or Without Low Dose Lung CT to Validate a Multi-Cancer Early Detection Blood Test (ID 1840)
09:45 - 18:00 | Presenting Author(s): Sam Janes
- Abstract
Background
Few effective screening tests exist for cancer, and each is specific to a single cancer type. A single blood test that directly measures tumor cell-free DNA and can detect several cancer types, including lung, pancreatic, colon, and head & neck cancers, with high specificity may reduce cancer burden. The SUMMIT Study is designed to validate the ability of an investigational blood test to detect multiple cancer types among a high-risk population undergoing LDCT for lung cancer screening, as well as in a lower risk population.
Method
SUMMIT is designed to enroll 50,000 participants aged 50-77, and will follow participants for up to 10 years via medical records and the national cancer registry. There will be two groups: Group A (n=25,000), individuals at high-risk for lung and other cancers due to substantial smoking history (per United States Preventive Services Task Force LDCT screening criteria, or PLCOm2012 six-year risk estimate of ≥1.3%); and Group B (n=25,000), individuals not meeting Group A criteria. Exclusion criteria include active cancer treatments. Potential participants are identified from the records of 540 general practices across North Central and East London, and are invited by letter to attend a dedicated LDCT scanning unit (Group A) or clinical unit (Group B), where eligibility is confirmed and consent obtained.
Group A participants will provide a blood sample, complete a questionnaire, and receive a baseline LDCT, and then provide a blood sample and complete a questionnaire at 12 and 24 months post-baseline. Those with a negative baseline LDCT (without lung nodules) will be randomised to either have a LDCT at 12 and 24 months or no further scans. Participants with lung nodules at baseline could have more frequent scans. Group B participants complete a questionnaire and provide a blood sample at three study appointments (baseline, 12 months, 24 months). The primary endpoint is cancer incidence and stage. Blood test performance will be determined by sensitivity and false-positive rates (specificity). Blood test results will not be returned to physicians or participants. Group A enrollment began in April 2019, and Group B enrollment is targeted to start later in 2019.
The study is designed to determine the performance and cost-effectiveness of this investigational multi-cancer blood test compared to or combined with LDCT for identifying lung cancer, and in detecting cancers for which there are no effective screening tests. The SUMMIT Study may therefore inform new approaches to finding cancer early.
Result
Section not applicable
Conclusion
Section not applicable
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-16 - TACTICAL: A Phase I/II Trial to Assess the Safety and Efficacy of MSCTRAIL in Metastatic Lung Adenocarcinoma (ID 794)
10:15 - 18:15 | Author(s): Sam Janes
- Abstract
Background
Mesenchymal stromal cells (MSCs) migrate to and incorporate into tumour stroma, acting as vehicles for delivering anti-cancer therapies. TNF-related apoptosis inducing ligand (TRAIL) selectively induces apoptosis in malignant cells, however its short biological half-life has limited therapeutic efficacy.
We have transduced MSCs with a lentiviral vector to express TRAIL (MSCTRAIL), demonstrating efficacy in vitro using co-culture assays and in vivo in orthotopic lung metastasis murine model, showing regression of metastases following treatment with intravenous MSCTRAIL [1] and synergistic activity with other systemic anti-cancer therapies.
Given their immune-privileged nature we are now delivering ex vivo MSCTRAIL from pooled third party umbilical cord donors without tissue matching or immunosuppression.
Method
TACTICAL is a phase I/II trial assessing safety and efficacy of MSCTRAIL in combination with first line standard of care (SOC); pemetrexed (500mg/m2) and cisplatin (75mg/m2) and/or pembrolizumab (200mg), in treatment-naive patients with stage IIIB/IV metastatic lung adenocarcinoma. Patients have no actionable driver mutations and ECOG performance status 0-1.
Phase I is a dose de-escalation study; patients receive SOC on day 1 and 4x108 MSCTRAIL cells on day 2 of a 21-day cycle for 3 cycles, with a Bayesian adaptive design recommending dose reductions if severe toxicities occur (Fig.1A). Primary outcomes are recommended phase II dose (RP2D), safety and tolerability of MSCTRAIL.
In phase II, 46 patients will be randomised (1:1) in a double-blind trial to receive SOC and either RP2D of MSCTRAIL or placebo (Fig.1B). Primary outcome is tumour response rate by RECIST (v1.1) at 12 weeks.
Result
Translational work will include measuring: biomarkers of response; T, B, NK cell function in reaction to allogeneic MSCs; tracking migration of MSCs radiolabelled with 89Zirconium-oxine through serial PET imaging.
Conclusion
TACTICAL is the first clinical trial of this novel cell and gene therapy and if successful will pave the way for future allogeneic MSC cancer therapies.
1. Loebinger, M.R., et al., Mesenchymal stem cell delivery of TRAIL can eliminate metastatic cancer. Cancer Res, 2009. 69(10): p. 4134-42.
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.02 - Lung Cancer Screenee Selection by USPSTF Versus PLCOm2012 Criteria – Interim ILST Findings (Now Available) (ID 2804)
08:00 - 10:15 | Author(s): Sam Janes
- Abstract
- Presentation
Background
The National Lung Screening Trial showed that lung cancer screening of high-risk individuals with low dose computed tomography can reduce lung cancer mortality by 20%. Critically important is enrolling high-risk individuals. Most current guidelines including the United States Preventive Services Task Force (USPSTF) and Center for Medicare and Medicaid Services (CMS) recommend screening using variants of the NLST eligibility criteria: smoking ≥30 pack-years, smoking within 15 years, and age 55-80 and 55-77 years. Many studies indicate that using accurate risk prediction models is superior for selecting individuals for screening, but these findings are based on retrospective analyses. The International Lung Screen Trial (ILST) was implemented to prospectively identify which approach is superior.
Method
ILST is a multi-centred trial enrolling 4000 participants. Individuals will be offered screening if they are USPSTF criteria positive or have PLCOm2012 model 6-year risk ≥1.5%. Participants will receive two annual screens and will be followed for six years for lung cancer outcomes. Individuals not qualifying by either criteria will not be offered screening, but samples of them will be followed for lung cancer outcomes. Outcomes in discordant groups, USPSTF+ve/PLCOm2012-ve and PLCOm2012+ve/USPSTF-ve, are informative. Numbers of lung cancers and individuals enrolled, sensitivity, specificity and positive predictive values (PPV) of the two criteria will be compared.
Result
As of March 2019, ILST centers in Canada (British Columbia), Australia, Hong Kong, and the United Kingdom had enrolled and scanned 3673 individuals. Study results are summarized in Figure 1.
Conclusion
Interim analysis of ILST data, indicates that classification accuracy of lung cancer screening outcomes support the PLCOm2012 criteria over the USPSTF criteria. The PLCOm2012 criteria detected significantly more lung cancers. Individuals who are USPSTF+ve and PLCOm2012-ve appear to be at such low baseline risk (0.2%) that they may be unlikely to benefit from screening.
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