16. Clinical Trials - Example 7 EGFR T790MΒΆ

Switch to the last sample NA12877-25-Horizon_S2 with the tissue type selection made for Lung-Non-Small Cell Lung Cancer

sample change

Figure 16-1: Patient Tab for sample NA12877-25-Horizon_S2.

Clicking again on the Mutation Profile Tab, the search for treatments will be specific for the oncogenic T790M variant in EGFR.

mutation profile tab

Figure 16-2: Mutation Profile Tab for EGFR T790M.

Notice again the pre-filled CancerKB interpretations for EGFR and T790M, as these interpretations will be automatically pulled into the final report. Reviewing treatment options, we see a number of FDA-Approved treatments for T790M.

EGFR T790M treatments

Figure 16-3: List of many FDA-Approved therapies for EGFR T790M.

Unfortunately, many of these drugs also have known submissions for drug resistance. This concern is relevant to the clinical trial search as some trials may take ineffective treatments into consideration as an inclusion criteria.

EGFR resistance

Figure 16-4: List of drugs with known resistance for EGFR T790M.

Moving to the Drug & Trials Tab, change the country back to United States and click on matching trials for Osimertinib. Also, deselect Recruiting Trials Only and select the NCT02917993 trial. You’ll notice that this trial is not currently recruiting but serves as a great example for specific inclusion criteria for troublesome biomarkers like T790M that infer resistance to treatments.

Osimertinib Trial

Figure 15-5: Clinical trial for Osimertinib.

Reviewing the details of the clinical trial at the bottom of the page, select the inclusion criteria as seen in the screenshot. Reading through these criteria, you’ll notice the requirements that the patient must have had prior EGFR TKI treatment, and only 1 prior treatment plus also be positive for the T790M mutation before acquiring the Osimertinib Itacinib combination therapy. Based on these inclusion criteria, this patient would be a prime candidate for the clinical trial to overcome issues with drug resistance for T790M.

Combo drug trial summary

Figure 16-6: Summary details for Osimertinib+Itacinib combination drug trial.

Now that the trial is selected, click on the Report Tab and confirm the sign out clicking on the green icon.

Report signout

Figure 16-7: Signout for clinical report.

With the new Drug & Trials feature, there is also a new clinical report template design to include the trial information. Click to select the “Cancer with Drugs and Trials Template V1” template. Then click Render.

Report template

Figure 16-8: Selecting the new report template supporting clinical trials.

Not only can users open the report in Microsoft word, but also convert the report to a pdf and open directly in VarSeq. Page 7 of the report contains the relevant clinical trial information for the Osimertinib and Itacitinib drug combination therapy.

Report template

Figure 16-9: Rendered report in pdf format.