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A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

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

NCT06382116•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent and follow the requirements of the protocol;
•2. Age ≥18 years old;
•3. Expected survival time ≥3 months;
•4. Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer;
•5. Documented classical EGFR mutations detected from tumor tissue or blood samples;
•6. Had not received any systemic therapy other than EGFR-TKIs;
•7. Radiographic disease progression documented during or after third-generation EGFR-TKI therapy for metastatic or locally advanced disease;
•8. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
•9. Must have at least one measurable lesion according to RECIST v1.1 definition;
•10. ECOG score 0 or 1;
+6 more criteria

Exclusion Criteria

•1. The patient has histologic or cytologic evidence of small cell or mixed small/non-small cell component or squamous non-small cell lung cancer;
•2. Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy has been used within 5 days, palliative radiotherapy or anti-tumor therapy has been used within 2 weeks;
•3. Previous treatment with: a. an ADC with TOPI inhibitor as toxin; b. any systemic therapy in the context of metastatic/locally advanced disease;
•4. The history of severe cardiovascular and cerebrovascular diseases in the past six months prior screening;
•5. Thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis more than 4 weeks later was excluded;
•6. Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrolled severe arrhythmia;
•7. Other malignancies diagnosed within 3 years before randomization;
•8. Hypertension poorly controlled by two antihypertensive drugs;
•9. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
•10. Patients with poor glycemic control;
+14 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

May 22, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

November 17, 2025

Enrollment

432

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

BL-B01D1

DRUG

Pemetrexed+Cisplatin or Carboplatin

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)