New AURORA Trial Tests Lung Cancer Drug After Immunotherapy Fails

A global phase 3 clinical trial called AURORA has opened enrollment to test whether an investigational immunotherapy can help patients with advanced non-small cell lung cancer (NSCLC) whose disease has continued to grow despite treatment with immune checkpoint inhibitors, Candel Therapeutics announced today.

The trial will compare aglatimagene besadenovec (CAN-2409) plus the antiviral drug valacyclovir, given alongside continued Keytruda (pembrolizumab), against standard chemotherapy with docetaxel. The study is enrolling patients with metastatic, non-squamous NSCLC whose cancer progressed after prior treatment with Keytruda and platinum-based chemotherapy, a group that currently has limited treatment options.

What Data Support Moving Aglatimagene Into a Phase 3 Trial?

The phase 3 trial builds on results from an earlier phase 2 study of aglatimagene in patients with advanced NSCLC who had an inadequate response to immune checkpoint inhibitors. In that study, half of the 46 patients who completed the full treatment protocol survived more than 24 months, despite having a poor response to prior immunotherapy and other unfavorable health factors at the start of treatment. Among patients with non-squamous NSCLC whose cancer was growing at the start of the study despite prior checkpoint inhibitor treatment, the group most similar to those now eligible for the phase 3 trial, median overall survival reached 25.4 months.

By comparison, the press release noted that docetaxel, the current standard treatment for this patient population, has historically been associated with a median overall survival of 9.8 to 11.8 months in prior research.

How Will the AURORA Trial Be Structured?

AURORA (NCT07660094) is a global, randomized, open-label phase 3 trial expected to enroll patients across approximately 150 sites worldwide. Patients will be randomly assigned in equal numbers to one of two treatment groups: aglatimagene plus valacyclovir for two courses of injections combined with continued Keytruda, or standard chemotherapy with docetaxel. The trial's main goal, known as the primary endpoint, is overall survival. Researchers will also track safety and quality of life using patient-reported measurement tools.

The first study site has opened and is now accepting patients.

Aglatimagene works by delivering a gene to the tumor that helps convert the antiviral drug valacyclovir into a substance that can damage and kill cancer cells. This process is designed to trigger the immune system to recognize and respond to the tumor, both at the site of injection and in other areas of the body where cancer has spread. The treatment is not approved by the FDA or any other regulatory agency for any use and remains investigational. The FDA has previously granted aglatimagene fast track designation for the treatment of NSCLC.

What Is Known About the Safety of Aglatimagene So Far?

According to Candel Therapeutics, more than 1,000 patients with cancer have received aglatimagene across its clinical development program, and the treatment has shown a favorable tolerability profile to date. Safety will continue to be tracked as a secondary endpoint throughout the AURORA trial, alongside quality-of-life outcomes, as researchers compare the experimental combination treatment with standard chemotherapy.

References

1. "Candel Therapeutics Announces Initiation of Global Pivotal Phase 3 AURORA Trial Evaluating Aglatimagene Besadenovec (CAN-2409) in Advanced Non-Small Cell Lung Cancer Patients with Inadequate Response to Immune Checkpoint Inhibitors" News Release. Candel Therapeutics, June 30, 2026.

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