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New treatment option for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07329322
What this study is testing
What is Sacituzumab Tirumotecan?
Sacituzumab Tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma...
- 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.
See the full eligibility 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...
- Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.