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

Conditions

• Non-squamous, Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aglatimagene Besadenovec — BIOLOGICAL
  via intratumoral injections into lung or lymph nodes at two timepoints
• Valacyclovir — DRUG
  Oral, for14 days following each aglatimagene besadenovec injection
• Pembrolizumab — BIOLOGICAL
  every 3 weeks (Q3W) or every 6 weeks (Q6W)
• Docetaxel — DRUG
  every 21 days with standard premedication

Study Details

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.

Key Dates

Start date

Jun 15, 2026

Status verified

Jun 2026

Primary completion

Oct 22, 2031

Completion

Oct 22, 2031

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1:Continued pembrolizumab with two courses of Aglatimagene besadenovec plus prodrug
  Patients continue to receive pembrolizumab with two courses of Aglatimagene besadenovec plus valacyclovir
• Active Comparator: Arm 2: Docetaxel
  Patients receive standard of care docetaxel

Primary Outcome Measure

Overall Survival [ Time Frame: From date of randomization until date of death from any cause, assessed for a minimum of 24 months ]

Locations (1)

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