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UCLA Clinical Trials news for September, 2017

News on 4 Clinical Trials at UCLA and TRIO-US facilities:

1. Phase 3 Trial for EGFRm Positive NSCLC Now Open

UCLA  announces the opening of CheckMate 722, a phase 3 trial for patients with stage IV or recurrent NSCLC, who test positive for EGFR mutations.  CheckMate 722 is restricted to patients who have progressed on prior EGFR-targeted (TKI) therapies. Patients must also test negative for T790M mutation. PD-L1 expression will be assessed, but will not be used as a criterion for study participation. Enrolled patients will be randomized to receive either: nivolumab with platinum-doublet chemotherapy; nivolumab with ipilimumab; or platinum-doublet chemotherapy alone. CheckMate 722 is now open to enrollment at UCLA Main Campus.

2. Lilly JVCY Study Expands to Select TRIO-US Sites

The Lilly 14T-MC-JVCY-NSCLC study will now be open at select sites in the TRIO-US Network. This is a randomized, double-blind study of EGFR inhibitor erlotinib in combination with anti-VEGF an body ramucirumab or placebo in previously untreated patients with metastatic NSCLC that is positive for EGFR mutation.

The trial will now be available at the following sites (site PIs in parentheses):

Bakers eld, CA (Dr. Ravi Patel); Fort Wayne, IN (Dr. Ahad Sadiq); Paducah, KY (Dr. Winston Chua); Santa Maria, CA (Dr. Robert Dichmann); Wichita, KS (Dr. Shaker Dakhil)

3. Phase 1b NSCLC Study of Anti-PD-1 Anti- body with Chemotherapy Now Open

The Novar s CPDR001C2101 study is now open to enrollment at UCLA Main Campus, UCLA Burbank, UCLA Pasadena, UCLA Torrance, UCLA Valencia, UCLA Ventura, and UCLA Westlake Village sites. This trial will investigate the anti-PD-1 antibody PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients.

Patients must have locally advanced or metastatic NSCLC, which can be either squamous or non-squamous. They must also be negative for EGFR mutations, ALK rearrangement, and ROS1 rearrangement. There are cohorts for both patients who have not received systemic cancer therapy and patients who have received only one prior systemic therapy for NSCLC consisting of a PD-1/PD-L1 inhibitor with or without a CLTA4 inhibitor.

4. KEYNOTE 407 Trial for Metastatic, Squamous NSCLC Expected to Complete Enrollment Soon

The KEYNOTE 407 trial is expected to be have filled all open spots for patients in the near future. This double-blinded phase 3 trial is for patients with metastatic, squamous NSCLC, who have not previously received systemic therapy. Patients receive either pembrolizumab or saline placebo with chemotherapy (carboplatin + paclitaxel OR nab-paclitaxel). KEYNOTE 407 is currently open to enrollment at the UCLA Main Campus, UCLA Pasadena, and UCLA Westlake Village sites.
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