Osimertinib / Non Small Cell Lung Cancer · Phase 2 Trial

Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

ClinicalTrials.gov · August 20, 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 Phase 2 trial registration for sacituzumab tirumotecan plus osimertinib in resectable EGFR-mutated NSCLC, currently recruiting. No results have been posted in the registry record. The study aims to evaluate safety and efficacy using Major Pathological Response as the primary endpoint.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Non-Small Cell Lung Cancer; age from 18 Years; to 75 Years. Intervention: Sacituzumab Tirumotecan+Osimertinib. n = 30. 1 site: China.

Key findings

Safety

This is a registry record with no posted results; no efficacy, safety, or outcome data are reported.

Who this may help

This is a study registration only; clinicians should not interpret any efficacy or safety findings from this record as results are not yet posted. The registration describes a planned study designed to generate early Phase 2 efficacy and safety data in the neoadjuvant setting.

Plain-language summary

This is a Phase 2 trial registration with no posted results; it describes a planned neoadjuvant study in a specific population but cannot yet demonstrate efficacy or safety.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Major Pathological Response (MPR) rate (assessed at up to 60 months)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationNon-Small Cell Lung Cancer; age from 18 Years; to 75 Years

Sample size30

InterventionSacituzumab Tirumotecan+Osimertinib

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment30

PhasePhase 2

Primary outcome measureMajor Pathological Response (MPR) rate

Follow-up durationup to 60 months

Clinical bottom line

Caveats

This is a registry record with no posted results; no efficacy, safety, or outcome data are reported.
Specific eligibility criteria, randomization method, and blinding status are not detailed in this registry excerpt.
Primary outcome is a surrogate endpoint (MPR); hard clinical outcomes (survival, recurrence-free survival) are not mentioned.
Study is still recruiting; enrollment and follow-up are incomplete.

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

moderate

Phase 2 interventional design specified; neoadjuvant setting is appropriate for early efficacy signals.

Directness

moderate

Primary outcome is Major Pathological Response, a surrogate; hard endpoint (survival) not stated.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study is recruiting; methods for blinding, allocation concealment not detailed in registry.

Sample adequacy

limited

Estimated enrollment 30 participants; typical Phase 2 size but relatively small for definitive claims.

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 (NCT07329322). This is a study registration, not published results. Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer. Interventions: DRUG: Sacituzumab Tirumotecan; DRUG: Osimertinib. Primary outcome measures: Major Pathological Response (MPR) rate , up to 60 months. Brief summary: The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.

Follow from this

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

OsimertinibNCT07329322Sichuan Kelun-Biotech Biopharmaceutical Co.Non Small Cell Lung Cancer