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NCT04495153 (Aglatimagene besadenovec in Stage III/IV NSCLC): BVCT ex-ante prediction vs. reported outcome

On 9 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe insufficient.

Clinical Trial

NCTID
NCT04495153
Drug Name
Aglatimagene besadenovec (CAN-2409)
Drug MoA
AAV-mediated intratumoral delivery of HSV-TK as an oncolytic viral therapy
Drug Modality
oncolytic viral gene therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Stage III/IV NSCLC
Human Patients
90
Sponsor
Candel Therapeutics
Phase
Phase 2

Prediction of , index 419

Prospective Prediction
Prediction Index
419
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS/OS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
44 days in advance
Readout Data Interpretation
20.6 months mOS (vs 11.6 mOS by docetaxel in a similar setting; yet the data's rigor has been questioned; and the SoC may be docetaxel + X combo (doi.org/10.1136/esmoopen-2017-000236).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients
Phase
Phase 2
Status
Active not recruiting
Enrollment
90
Lead sponsor
Candel Therapeutics, Inc.
Conditions
Non Small Cell Lung Cancer
Interventions
BIOLOGICAL: Aglatimagene besadenovec
Design
Single group · None
Primary purpose
Treatment
Start
2020-10-13
Primary completion
2024-12-31
Completion
2026-12
Primary outcomes
  • Response rate (12 months)
  • Safety graded by CTCAE version 5.0 (12 weeks)

NCT04495153 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials