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NCT05208944 (Cemiplimab in 3L advanced NSCLC): BVCT ex-ante prediction vs. reported outcome

On 2 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 4 Feb 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (3L).

Clinical Trial

NCTID
NCT05208944
Acronym
THIO-101
Drug Name
Cemiplimab
Drug MoA
telomere-targeting agent THIO
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
3L advanced NSCLC
Human Patients
182
Sponsor
Maia Biotechnology
Phase
Phase 2

Prediction of , index 1777

Prospective Prediction
Prediction Index
1777
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate additive clinical benefit in OS in combination with cemiplimab superior to chemotherapy + cemiplimab as 3L+ treatment) partial FAILURE (commercially insufficient additive clinical benefit in OS in combination with cemiplimab non-superior to chemotherapy + cemiplimab as 2L treatment)
Technical Prediction
partial SUCCESS (statistically significant moderate additive clinical benefit in ORR/PFS as 3L+ treatment) partial FAILURE (statistically maybe significant yet very weak additive clinical benefit in ORR/PFS as 2L treatment)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
155 days in advance
Readout Data Interpretation
THIO + cemiplimab achieved 16.9 months mOS (12.5 months mOS as the 95% CI lower bound); superior to the SoC chemotherapy that achieved 10.1 months mOS (see the add'l link below). wait for 2L data.
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (3L)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase
Phase 2
Status
Active not recruiting
Enrollment
227
Lead sponsor
Maia Biotechnology
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG: 6-Thio-2'-Deoxyguanosine; DRUG: Cemiplimab
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2022-06-08
Primary completion
2027-09-30
Completion
2027-12-31
Primary outcomes
  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC (Up to 2 years)
  • To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC (Up to 2 years)
  • To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC (Up to 2 years)
  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC (Up to 2 years)
  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC (Up to 2 years)

NCT05208944 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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