Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmacosmos A/S
About this trial
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
Qualifiers
ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
Measurable or evaluable disease as defined by RECIST v1.1
Disqualifiers
History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
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
Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
Radiotherapy within 2 weeks
Trial design
Treatments tested in this trial
- Trilaciclib
- Placebo
- Topotecan
Treatment groups
302 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov