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

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

Trial Details

NCT ID
NCT07660094
Phase
PHASE3
Sponsor
Candel Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Aglatimagene Besadenovec
  • Valacyclovir
  • Pembrolizumab
  • Docetaxel
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Age ≥ 18 years, at the time of signing the informed consent.
  • Histologically confirmed metastatic Stage IV non-squamous NSCLC.
  • Measurable disease per RECIST v1.1 with at least 1 thoracic lesion amenable to intratumoral injection (e.g., pathological lymph node or lung lesion).
  • Note: Able to be reached by bronchoscopy (including robotic bronchoscopy or flexible bronchoscopy with or without endobronchial ultrasound), or by …

For full eligibility, visit ClinicalTrials.gov.

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