At a glance
ClinicalIndex Comparison RecordPhase 3Active· 432 enrolled
Drug / intervention
BL-B01D1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure
In Brief
A Phase 3 clinical trial evaluating BL-B01D1 and Pemetrexed+Cisplatin or Carboplatin for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 432 participants across 1 site.
Detailed Summary
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
CollaboratorsBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Timeline
Phase 3ActiveOverdue
20252026
First PostedApr 2024
Enrollment StartMay 2024
Primary CompletionMay 2026
TodayJul 2026
First PostedApr 24, 2024
Enrollment StartMay 22, 2024
Primary CompletionMay 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.9 yearsPosted 2.2 years ago
Interventions
BL-B01D1drug
Administration by intravenous infusion for a cycle of 3 weeks.
Pemetrexed+Cisplatin or Carboplatindrug
Administration by intravenous infusion for a cycle of 3 weeks.