Health TrialsbyHealthPanel

Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

ConditionExtensive-stage Small-cell Lung Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Trilaciclib

    Drug

    Participants will receive intravenous trilaciclib infusion

  • Placebo

    Drug

    Participants will receive intravenous placebo infusion

  • Topotecan

    Drug

    Participants will receive intravenous topotecan infusion

Treatment groups

302 Participants
are divided into 2 treatment groups
Group A: Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m²Experimental treatment 2 interventions
Group B: Placebo + Topotecan 1.5 mg/m²Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan

Time frame
From date of randomization until date of death due to any cause for those who died; or date of last contact known as alive for those who survived in the study (censored cases), assessed up to 52 months

Secondary outcomes

1

Anti-tumor efficacy

To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan

Time frame
From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first, assessed up to 52 months
2

Anti-tumor efficacy

To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan

Time frame
From date of randomization until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, assessed up to 52 months
3

Anti-tumor efficacy

To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan

Time frame
From date of first objective response of complete response (CR) or partial response (PR) and the first date that progressive disease is objectively documented or death, whichever comes first, assessed up to 52 months
4

Neutrophil-related myeloprotection efficacy

Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1

Time frame
From date of randomization until end of cycle 1 (each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmacosmos A/S

Lead sponsor

Source ClinicalTrials.gov
Apply now