Clinical Trial: NCT06382116
A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief 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.
Official Title
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Pemetrexed+Cisplatin or Carboplatin
Other Study ID Numbers
- BL-B01D1-301
Start Date (Actual)
2024-05-22
Primary Completion Date (Estimated)
2026-08
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
432
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief 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.
Official Title
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
Conditions
Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Pemetrexed+Cisplatin or Carboplatin
Other Study ID Numbers
- BL-B01D1-301
Start Date (Actual)
2024-05-22
Primary Completion Date (Estimated)
2026-08
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
432
Study Type
Interventional
Phase
Phase 3