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NCT07660094 · ClinicalTrials.gov registry record · Phase 3
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA)
A Phase 3 study, sponsored by Candel Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT07660094: Recruiting Phase 3 study, sponsored by Candel Therapeutics.
NCT07660094 is a Phase 3 study that is actively recruiting participants, run by Candel Therapeutics. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07660094, a Phase 3 study, is actively recruiting participants, sponsored by Candel Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate whether treatment with aglatimagene besadenovec (CAN-2409) plus valacyclovir and continued pembrolizumab improves overall survival (OS) compared to standard of care (SoC) docetaxel chemotherapy, in participants with Stage IV non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following prior pembrolizumab-based platinum chemoimmunotherapy
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Docetaxel
- DRUG Valacyclovir
- BIOLOGICAL Aglatimagene Besadenovec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2031-10-22 |
| Phase | Phase 3 |
What NCT07660094 shows while recruiting
NCT07660094 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT07660094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07660094 about?
NCT07660094 is a clinical study titled "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 encod...
What is the current status of trial NCT07660094?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2026-06-15. Estimated completion is 2031-10-22.
What interventions are being tested in trial NCT07660094?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Docetaxel (DRUG), Valacyclovir (DRUG), Aglatimagene Besadenovec (BIOLOGICAL).
Who is sponsoring clinical trial NCT07660094?
This trial is sponsored by Candel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07660094's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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