CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 40 target
Drug / intervention
BL-B01D1 +1 moredrug
Likely dose
BL-B01D1 2.5mg/kgfrom record
Key inclusion· 7
  • ✓Age 18-75 years
  • ✓Stage II-IIIB EGFR-sensitive mutation-positive NSCLC
  • ✓Feasible candidate for radical lobectomy with systematic lymph node dissection
  • ✓Assessed as requiring neoadjuvant therapy
Key exclusion· 13
  • ✕Prior systemic or local anti-tumor therapy for NSCLC
  • ✕Other malignancy within 5 years (except specified skin/in situ cancers)
  • ✕Major surgery within 4 weeks before first dose
  • ✕Active or history of interstitial lung disease or drug-induced pneumonia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06951464
NCT06951464Phase 2RecruitingOn TrackUpdated 11mo ago
CompareCT.gov

A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer

Sichuan University·interventional·Posted Apr 30, 2025·Updated Jul 23, 2025

In Brief

A Phase 2 clinical trial evaluating BL-B01D1 and Almonertinib for Non-Small Cell Lung Cancer. Currently recruiting, targeting 40 participants across 1 site.

Detailed Summary

This is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2026202720282029
First PostedApr 30, 2025
Enrollment StartJun 25, 2025
Primary CompletionMay 5, 2027
Study CompletionMar 5, 2029
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 1.2 years agoPrimary completion in 10 months

Interventions

BL-B01D1drug

BL-B01D1 (2.2 or 2.5mg/kg) to be administered on Day 1 and Day 8 of every 3-week cycle for 2 cycles.

Almonertinibdrug

Almonertinib 100mg QD