RecruitingPhase 3NCT07660094

Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)

A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment


Sponsor

Candel Therapeutics, Inc.

Enrollment

500 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial compares the effect of the combination of aglatimagene besadenovec and pembrolizumab versus standard of care docetaxel chemotherapy for the treatment of stage IV non-squamous, non-small cell lung cancer. Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral prodrug (valacyclovir), injection of aglatimagene induces targeted tumor cell death and stimulates a systemic immune response. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving aglatimagene with pembrolizumab is more effective at treating patients with stage IV non-squamous, non-small cell lung cancer than standard chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Aglatimagene Besadenovec, a drug called Docetaxel, and others for people with non-squamous non-small cell lung cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAglatimagene Besadenovec

via intratumoral injections into lung or lymph nodes at two timepoints

DRUGValacyclovir

Oral, for14 days following each aglatimagene besadenovec injection

BIOLOGICALPembrolizumab

every 3 weeks (Q3W) or every 6 weeks (Q6W)

DRUGDocetaxel

every 21 days with standard premedication


Locations(1)

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

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NCT07660094


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