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NCT05384626 (NVL-655 in Advanced NSCLC and Other Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 15 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 9 Sep 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (against placebo non-superior to lorlatinib) and commercially TBD.

Clinical Trial

NCTID
NCT05384626
Acronym
ALKOVE-1
Drug Name
NVL-655
Drug MoA
CNS-penetrant mutant-selective ALK inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced NSCLC and Other Solid Tumors
Human Patients
400
Sponsor
Nuvalent
Phase
Phase 1

Prediction of , index 1247

Prospective Prediction
Prediction Index
1247
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in OS without mutation-specific stratification; superior to lorlatinib for cohort 2a/2b/2c/2d/2e/2f; non-superior to alectinib for cohort 2c/2d/2e/2f)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in ORR/PFS against placebo for all cohorts; non-superior to lorlatinib/alectinib for cohort 2c/2d/2e/2f)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
25 days in advance
Readout Data Interpretation
NVL655 achieved 38% confirmed ORR vs. 48% confirmed ORR achieved by lorlatinib in NCT01970865.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (against placebo non-superior to lorlatinib) 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 Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
840
Lead sponsor
Nuvalent Inc.
Conditions
Locally Advanced Solid Tumor; Metastatic Solid Tumor
Interventions
DRUG: Neladalkib (NVL-655); DRUG: Midazolam; DRUG: Repaglinide; DRUG: Itraconazole
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-06-09
Primary completion
2027-12
Completion
2028-01
Primary outcomes
  • Dose limiting toxicities (DLTs) (Phase 1) (Within the first 21 days of the first neladalkib (NVL-655) dose)
  • Recommended Phase 2 Dose (RP2D) (Phase 1) (Within 21 days of last patient dosed during escalation)
  • Objective Response Rate (ORR) (Phase 2) (2-3 years after first patient dosed.)
  • Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1) (Approximately 3 years)
  • Area under the curve of repaglinide (Phase 2 DDI sub-study) (Pre-dose and up to 24 hours post-dose)

NCT05384626 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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