Non-Small Cell Lung CancerPhase 2NCT07329322
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
A Phase 2 study testing Sacituzumab Tirumotecan and Osimertinib in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Sacituzumab Tirumotecan and Osimertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 31 Oct 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed NSCLC.
- No prior systemic anti-tumor therapy.
- No prior local therapy for NSCLC.
- Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
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- At least one target lesion as assessed by the investigator according to RECIST v1.1.
- Life expectancy ≥ 24 weeks.
- Adequate organ and bone marrow function.
- For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose.
- Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.
Who cannot join
- Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.
- Participants with other malignant tumors within 3 years prior to randomization.
- Resting electrocardiogram (ECG) showing clinically significant abnormal results.
- Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Uncontrolled systemic diseases in the investigator's judgment.
- History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis.
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- Clinically severe lung damage due to complications of lung disorder.
- Participants who have received systemic corticosteroids therapy with > 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before randomization.
- Known active pulmonary tuberculosis.
- Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.
- Active hepatitis B.
- Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Known hypersensitivity to osimertinib, sacituzumab tirumotecan, or any of their components (including but not limited to polysorbate-20); known history of severe hypersensitivity to other biologics.
- Have received a live vaccine within 30 days prior to randomization, or plan to receive a live vaccine during the study.
- Pregnant or lactating women.
- Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that the investigator considers unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Jie He; Jie Wang, 010-87788207; 010-87788021, hejie@cicams.ac.cn; wangjiegcp@163.com
About this study
Official title: A Multicenter, Phase II Clinical 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
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.
Read the detailed description
This is a multicenter, Phase 2 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Sacituzumab Tirumotecan, Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab TirumotecanDrug
Sacituzumab Tirumotecan: 4mg/kg, intravenous (IV) infusion
OsimertinibDrug
80mg, QD
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan+Osimertinib | Experimental | Participants will receive Sacituzumab Tirumotecan for each 2-week cycle, Osimertinib once-daily for each 2-week cycle. Receives: Drug: Sacituzumab Tirumotecan; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) rate
MPR rate is defined as the proportion of participants achieving ≤ 10% residual viable tumor cells in the postoperative surgical specimen.
Measured: up to 60 months
Secondary outcomes (13)
pathological Complete Response (pCR) rate
pCR rate is defined as the proportion of participants achieving absence of any residual viable tumor cells in the postoperative surgical specimen.
Measured: up to 60 months
Residual viable tumor percentage (RVT%)
RVT% is defined as the proportion of residual viable tumor cells in the postoperative surgical specimen.
Measured: up to 60 months
R0 resection rate
Proportion of participants achieving R0 resection
Measured: up to 60 months
Pathological lymph node downstaging rate
Pathological lymph node downstaging rate is defined as the proportion of participants achieving pathological lymph node downstaging
Measured: up to 60 months
Pathological primary tumor downstaging rate
Pathological primary tumor downstaging rate is defined as the proportion of participants achieving pathological primary tumor downstaging
Measured: up to 60 months
ORR
ORR is defined as a partial or complete response according to RECIST, version 1.1.
Measured: up to 60 months
EFS
EFS is defined as the time from randomization to progression of disease, recurrence of disease, or death from any cause.
Measured: up to 60 months
DFS
DFS is defined as the time from surgery to disease progression (recurrence or metastasis) or death due to any cause.
Measured: up to 60 months
OS
OS is defined as the time from randomization to death from any cause.
Measured: up to 60 moths
Incidence of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0
Incidence (based on NCI CTCAE v5.0) of adverse events (AEs) and serious adverse events (SAEs).
Measured: up to 60 months
Severity of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0
Severity (based on NCI CTCAE v5.0) of adverse events (AEs) and serious adverse events (SAEs).
Measured: up to 60 months
Maximum observed plasma concentration (Cmax) of Sacituzumab Tirumotecan-ADC, Sacituzumab Tirumotecan-TAB, and free KL610023
To assess the pharmacokinetic (PK) profile of Sacituzumab Tirumotecan.
Measured: up to 60 months
Anti-drug Antibodies (ADA) of Sacituzumab Tirumotecan
Immunogenicity test results of Sacituzumab Tirumotecan.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start30 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329322
- Sponsor's protocol ID
- SKB264-II-18
- Status last verified
- May 2026
- First submitted
- 11 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No