NCT06954246 A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
| NCT ID | NCT06954246 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Small Cell Lung Cancer Extensive Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2025-06-04 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following criteria to be eligible for randomization into the study: 1. Voluntarily consent to participate in this study and sign the informed consent form. 2. Adults ≥18 years, regardless of gender. 3. ECOG performance status score of 0-1. 4. Estimated survival time of more than 3 months. 5. Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures. 6. Has histologically or cytologically documented small cell lung cancer (SCLC). 7. 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 with or without platinum-based regimens. 8. Agrees to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers. 9. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator. 10. Sufficient bone marrow and organ function. Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form. 2. Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC. 3. 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 first dose. 4. Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads. 5. 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 of symptoms). 6. Bone marrow metastasis. 7. Prior B7-H3-targeted therapy. 8. Has uncontrolled or significant cardiovascular disease. 9. Moderate-to-severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy. 10. 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. 11. Moderate or severe pulmonary diseases severely affecting lung function. 12. 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. 13. Serious infections within 4 weeks before the first dose, including but not limited to those requiring systemic antibiotic therapy, bacteremia, or severe pneumonia. 14. Clinically uncontrolled third-space effusion requiring intervention, including pleural or peritoneal effusions. 15. Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., topotecan, irinotecan, paclitaxel). 16. Pregnant or lactating women, or women/men intending to conceive.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06954246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer Extensive Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06954246 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06954246 currently recruiting?
Yes, NCT06954246 is actively recruiting participants. Contact the research team at jwshi@minghuipharma.com for enrollment information.
Where is the NCT06954246 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06954246 clinical trial?
NCT06954246 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 450 participants.
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