Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmacosmos A/S

About this trial

The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:

Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?

Participants will be randomised to receive either trilaciclib or placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer

Complete recovery from prior anti-tumor surgical procedures

Measurable and evaluable disease through tumor assessment

Willingness to participate and sign informed consent form

Disqualifiers

Extensive Stage Small Cell Lung Cancer

Active cardiovascular disease

Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations

Pregnant or nursing women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trilaciclib

    Drug

    Intravenous infusion

  • Saline (0.9% NaCl)

    Drug

    Intravenous infusion

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TrilaciclibExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To Compare trilaciclib to placebo on prevention of myelosuppression

Duration and occurrence of severe neutropenia

Time frame
From enrollment and 4 months after

Secondary outcomes

1

Number of all-cause chemotherapy dose reductions

Time frame
From enrollment and 4 months after
2

Occurrence of granulocyte colony-stimulating factor (G-CSF) administration

Time frame
From enrollment and 4 months after
3

Number of hospitalizations due to myelosuppression or sepsis

Time frame
From enrollment and 4 months after
4

Number of febrile neutropenia

Time frame
From enrollment and 4 months after

Other outcomes

Sponsors and contacts

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