NCT06498986 is a Phase 2 clinical trial of BL-B01D1 in Non-small Cell Lung Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd..

Who is sponsoring NCT06498986?

NCT06498986 is sponsored by Sichuan Baili Pharmaceutical Co., Ltd..

What drugs are being tested in NCT06498986?

Interventions in NCT06498986: BL-B01D1, Osimertinib Mesylate Tablets.

What condition does NCT06498986 study?

NCT06498986 studies Non-small Cell Lung Cancer.

Is NCT06498986 still recruiting?

NCT06498986 is currently recruiting now. Last updated 5 May 2025.

Last reviewed 2025-05-05 · How we verify

NCT06498986

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting now Phase 2 Last updated 5 May 2025

What this trial tests

Phase 2 trial testing BL-B01D1 in Non-small Cell Lung Cancer in 40 participants. Currently enrolling.

Timeline

31 July 2024

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	Sichuan Baili Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	31 July 2024
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across China

Drugs / interventions tested

BL-B01D1 — full drug profile →
Osimertinib Mesylate Tablets — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Recommended Phase II Dose (RP2D)
Time frame: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
Objective response rate (ORR)
Time frame: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

Sponsor's own description

This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeted therapy of non-small cell lung cancer: mechanisms and clinical trials.
Yu L, Yang R, Long Z, Tao Q, et al · · 2024 · cited 12× · PMID 39391239 · DOI 10.3389/fonc.2024.1451230

Verify or expand the search:

Other trials of BL-B01D1

Trials testing the same drug.

NCT07307053 — Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) · Phase 1, PHASE2 · not yet recruiting
NCT06951464 — A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC · Phase 2 · recruiting
NCT05983432 — Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors · Phase 1 · recruiting

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Sichuan Baili Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT05039944 — SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies · Phase 2 · terminated
NCT04851444 — A Study of SI-F019 in Healthy Participants · Phase 1 · completed
NCT03853369 — Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection · unknown
NCT03855826 — Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection. · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06498986 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sichuan Baili Pharmaceutical Co., Ltd.
Last refreshed: 5 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06498986.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing