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NCT05118789 (Zidesamtinib in Advanced NSCLC and Other Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 15 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD.

Clinical Trial

NCTID
NCT05118789
Acronym
ARROS-1
Drug Name
Zidesamtinib (NVL-520)
Drug MoA
CNS-penetrant mutant-selective ROS1 inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced NSCLC and Other Solid Tumors
Human Patients
359
Sponsor
Nuvalent
Phase
Phase 1 Phase 2

Prediction of , index 1248

Prospective Prediction
Prediction Index
1248
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS superior to repotrectinib for tumors with ROS1 fusion without TRK fusion)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS against placebo non-inferior to repotrectinib for tumors with ROS1 fusion without TRK fusion)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
313 days in advance
Readout Data Interpretation
Zidesamtinib achieved 44% ORR; superior to pembrolizumab + ipilimumab that achieved 20-30% confirmed ORR for EGFRwt advanced NSCLC patients (see DOI-10.1016/j.lungcan.2018.12.015) and slightly superior to repotrectinib that achieved 38% ORR for ROS1-positive advanced NSCLC (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
359
Lead sponsor
Nuvalent Inc.
Conditions
Locally Advanced Solid Tumor; Metastatic Solid Tumor
Interventions
DRUG: Zidesamtinib (NVL-520)
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-01-04
Primary completion
2027-12-31
Completion
2028-12-31
Primary outcomes
  • Maximum Tolerated Dose (MTD) (Phase 1) (Within 28 days of last patient dosed during dose escalation)
  • Recommended Phase 2 Dose (RP2D) (Within 28 days of last patient dosed during dose escalation.)
  • Objective Response Rate (ORR) (Phase 2) (2-3 years after first patient dosed.)

NCT05118789 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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