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NCT06726265 (Eftilagimod Alfa in Advanced/Metastatic Non-Small Cell Lung Cancer): BVCT ex-ante prediction vs. reported outcome

On 16 Nov 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 13 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (numerically superior) and commercially TBD (pending OS data).

Clinical Trial

NCTID
NCT06726265
Acronym
TACTI-004
Drug Name
Eftilagimod Alfa (Efti)
Drug MoA
soluble LAG3 fusion protein as an MHC class II agonist
Drug Modality
protein
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Human Patients
756
Sponsor
Immutep Limited
Phase
Phase 3

Prediction of , index 2092

Prospective Prediction
Prediction Index
2092
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in OS slightly-to-moderately superior to pembrolizumab + chemotherapy for 1L NSCLC)
Technical Prediction
SUCCESS (statistically significant yet moderate additive clinical benefit in ORR/PFS numerically-to-slightly superior to pembrolizumab + chemotherapy for 1L NSCLC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
117 days in advance
Readout Data Interpretation
eftilagimod + pembrolizumab + chemotherapy is deemed unlikely to deliver more than numerically superior PFS at early interim analysis and the trial has been discontinued for futility
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (numerically superior) and commercially TBD (pending OS data)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.
Phase
Phase 3
Status
Active not recruiting
Enrollment
756
Lead sponsor
Immutep S.A.S.
Conditions
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
BIOLOGICAL: eftilagimod alfa; DRUG: carboplatin plus paclitaxel; DRUG: cisplatin or carboplatin + pemetrexed; BIOLOGICAL: pembrolizumab (KEYTRUDA®); OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2025-03-21
Primary completion
2027-06
Completion
2029-09
Primary outcomes
  • Determination of Overall survival (OS) (Up to approximately 54 months)
  • Determination of Progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 54 months)

NCT06726265 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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