NCT05874401 Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
| NCT ID | NCT05874401 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Pharmacosmos A/S |
| Condition | Extensive-stage Small-cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 302 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2027-10-30 |
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 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 302 participants in total. It began in 2023-10-18 with a primary completion date of 2027-10-30.
⚠ 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 is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.
Eligibility Criteria
Inclusion Criteria: 1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology 2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination. 3. Measurable or evaluable disease as defined by RECIST v1.1 Exclusion Criteria: 1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC 2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer 3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 4. Radiotherapy within 2 weeks 5. History of ILD/pneumonitis 6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Contact & Investigator
Pharmacosmos Clinical and non-clinical Department
STUDY DIRECTOR
Pharmacosmos A/S
Frequently Asked Questions
Who can join the NCT05874401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extensive-stage Small-cell Lung Cancer. 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 NCT05874401 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05874401 currently recruiting?
Yes, NCT05874401 is actively recruiting participants. Contact the research team at info@pharmacosmos.com for enrollment information.
Where is the NCT05874401 trial being conducted?
This trial is being conducted at Seville, Spain.
Who is sponsoring the NCT05874401 clinical trial?
NCT05874401 is sponsored by Pharmacosmos A/S. The principal investigator is Pharmacosmos Clinical and non-clinical Department at Pharmacosmos A/S. The trial plans to enroll 302 participants.
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