BridgeMD
Compares treatment options for Small Cell Lung Cancer Extensive Stage
Official title A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06954246
What this study is testing
What is MHB088C for Injection?
MHB088C for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer extensive stage.
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
- This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Voluntarily consent to participate in this study and sign the informed consent form.
- Adults ≥18 years, regardless of gender.
- ECOG performance status score of 0-1.
- Estimated survival time of more than 3 months.
You likely can't join if
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
- Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.
- Receipt of chemotherapy within 4 weeks prior to the first administration of study drug, or receipt of radiotherapy, biologics, endocrine therapy...
- Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor...
- Brain metastases (unless asymptomatic and stable for more than 4 weeks prior to randomization); presence of leptomeningeal metastases or brainstem...
See the full eligibility criteria
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Voluntarily consent to participate in this study and sign the informed consent form.
- Adults ≥18 years, regardless of gender.
- ECOG performance status score of 0-1.
- Estimated survival time of more than 3 months.
- Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
- Has histologically or cytologically documented small cell lung cancer (SCLC).
- Extensive-stage SCLC with disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy, with no more than two prior lines of therapy. Prior PD-1/L1 systemic therapy was allowed to use...
- Agrees to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers.
- Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
- Sufficient bone marrow and organ function.
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
- Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.
- Receipt of chemotherapy within 4 weeks prior to the first administration of study drug, or receipt of radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks prior to the...
- Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.
- Brain metastases (unless asymptomatic and stable for more than 4 weeks prior to randomization); presence of leptomeningeal metastases or brainstem metastases; spinal cord compression (identified via imaging, regardless...
- Bone marrow metastasis.
- Prior B7-H3-targeted therapy.
- Has uncontrolled or significant cardiovascular disease.
- Moderate-to-severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
- Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
- Moderate or severe pulmonary diseases severely affecting lung function.
- Active tuberculosis, autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases, or history of allogeneic stem cell, bone marrow, or organ transplantation.
- Serious infections within 4 weeks before the first dose, including but not limited to those requiring systemic antibiotic therapy, bacteremia, or severe pneumonia.
- Clinically uncontrolled third-space effusion requiring intervention, including pleural or peritoneal effusions.
- Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., topotecan, irinotecan, paclitaxel).
- Pregnant or lactating women, or women/men intending to conceive.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.