NEW YORK CITY — Candel Therapeutics initiated the global pivotal phase 3 AURORA trial on June 30, 2026. The trial evaluates aglatimagene besadenovec plus valacyclovir in combination with continued pembrolizumab for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.

The AURORA trial is expected to enroll patients across approximately 150 sites globally. Patients will be randomized 1:1 to receive either aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy. The primary endpoint is overall survival. The U.S. Food and Drug Administration previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC. Candel Therapeutics engaged Parexel International to support the execution of the trial, and the first site is now open for enrollment.

Roy Herbst, Deputy Director and Chief of Medical Oncology and Hematology at Yale Cancer Center, said, "Patients whose lung cancer progresses despite immune checkpoint inhibitor therapy have limited treatment options, and outcomes with standard chemotherapy remain poor." He added, "The survival results observed with aglatimagene in the phase 2 trial are particularly encouraging and support advancing the program into the pivotal phase 3 AURORA trial."

The AURORA trial builds on results from Candel's phase 2 clinical trial (NCT04495153). In that trial, 50% of 46 per-protocol patients survived beyond 24 months. For evaluable patients with non-squamous histology and progressive disease at baseline, median overall survival was 25.4 months. Docetaxel, a standard-of-care treatment, delivers a median overall survival of 9.8 to 11.8 months. Charu Aggarwal serves as a co-Principal Investigator for the AURORA trial.

Paul Peter Tak, President and Chief Executive Officer of Candel, said, "This is a pivotal moment for Candel and, most importantly, for the patients we aim to serve." He also stated, "Disease progression following ICI therapy remains associated with poor survival outcomes and a substantial unmet medical need," and added, "Building on our completed phase 2 clinical trial, we have refined the target patient population by integrating clinical and biomarker insights to maximize the likelihood of success of the phase 3 trial."

Lung cancer is the leading cause of cancer death in the United States, with non-small cell lung cancer accounting for approximately 77% of all lung cancer cases. Approximately 60% of patients experience disease progression within one year of immune checkpoint inhibitor therapy.