BL-B01D1 / Osimertinib / Non Small Cell Lung Cancer Stage III · Phase 3 Trial

A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry entry for a planned Phase 3 randomized study comparing BL-B01D1 plus osimertinib versus osimertinib monotherapy in EGFR-mutated Stage III NSCLC post-chemoradiotherapy. No results are reported in this registry record; the trial is currently recruiting participants.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-small Cell Lung Cancer Stage III; age from 18 Years; to 75 Years. Intervention: BL-B01D1+Osimertinib. Compared with: Osimertinib — Active Comparator. n = 418. 1 site: China.

Key findings

Safety

No efficacy or safety data available; clinical impact cannot be determined until results are published.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned Phase 3 study with no results reported; the trial is actively recruiting and outcome data are not yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-free survival (PFS) (assessed at Up to approximately 24 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNon-small Cell Lung Cancer Stage III; age from 18 Years; to 75 Years

Sample size418

InterventionBL-B01D1+Osimertinib

ComparatorOsimertinib — Active Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment418

PhasePHASE 3

Primary outcome measureProgression-free survival (PFS)

Follow-up duration for primary outcomeUp to approximately 24 months

Caveats

This is a registry record only; no results are reported and the trial is actively recruiting.
Study is open-label, which may introduce performance and detection bias.
Comparator arm (osimertinib alone) dosing and schedule not detailed in this registry entry.
No efficacy or safety data available; clinical impact cannot be determined until results are published.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, open-label, multicenter Phase 3 design appropriate for regulatory registration.

Directness

strong

Primary endpoint is progression-free survival, a clinically relevant hard endpoint.

Consistency

insufficient

Registry record only; no results reported; consistency cannot be assessed.

Risk of bias

insufficient

Open-label design noted; no results data available to assess outcome bias.

Sample adequacy

strong

Planned enrollment of 418 participants is adequate for Phase 3 registration trial.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07640789). This is a study registration, not published results. Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 418 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer Stage III. Interventions: DRUG: BL-B01D1; DRUG: Osimertinib. Primary outcome measures: Progression-free survival (PFS) , Up to approximately 24 months. Brief summary: This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07640789BL-B01D1OsimertinibNon Small Cell Lung Cancer Stage IIISichuan Baili Pharmaceutical Co.