Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacituzumab Tirumotecan, Osimertinib.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib or as Monotherapy for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Overview
The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
Detailed description
This is a randomized, open-label, multicenter, Phase 2 study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.
Interventions
- Drug Sacituzumab Tirumotecan
Sacituzumab Tirumotecan: 4mg/kg, intravenous (IV) infusion - Drug Osimertinib
80mg, QD
Primary outcome measures
- Major Pathological Response (MPR) rate [Time frame: up to 60 months]
Secondary outcome measures (12)
- pathological Complete Response (pCR) rate [Time frame: up to 60 months]
- Residual viable tumor percentage (RVT%) [Time frame: up to 60 months]
- R0 resection rate [Time frame: up to 60 months]
- Pathological lymph node downstaging rate [Time frame: up to 60 months]
- Pathological primary tumor downstaging rate [Time frame: up to 60 months]
- ORR [Time frame: up to 60 months]
- EFS [Time frame: up to 60 months]
- DFS [Time frame: up to 60 months]
- OS [Time frame: up to 60 moths]
- Incidence of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0 [Time frame: up to 60 months]
- Severity of Adverse events (AEs) and serious adverse events (SAEs) as assessed by NCI CTCAE v5.0 [Time frame: up to 60 months]
- Maximum observed plasma concentration (Cmax) of Sacituzumab Tirumotecan-ADC, Sacituzumab Tirumotecan-TAB, and free KL610023 [Time frame: up to 60 months]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07329322 · SKB264-II-18