Extensive-stage Small-cell Lung CancerPhase 4NCT05874401
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
A Phase 4 study testing Trilaciclib and Topotecan in people with Extensive-stage Small-cell Lung Cancer, run by Pharmacosmos A/S at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Trilaciclib and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteSpain
- Study dates
- 13 Oct 2023to 5 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- History of ILD/pneumonitis
- History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
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.
Read the detailed description
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Trilaciclib, Placebo, Topotecan
- Keywords
- myelosuppression, ES-SCLC, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, myeloprotection
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor
Participants will receive intravenous trilaciclib infusion
PlaceboDrug
Participants will receive intravenous placebo infusion
TopotecanDrug
Also called Hycamtin
Participants will receive intravenous topotecan infusion
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² | Experimental | Patients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²) Receives: Drug: Trilaciclib; Drug: Topotecan |
| Placebo + Topotecan 1.5 mg/m² | Placebo comparator | Patients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.
Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²). Receives: Drug: Placebo; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan
Measured: 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 (16)
Anti-tumor efficacy
To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving Topotecan
Measured: 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
Anti-tumor efficacy
To assess the effect of trilaciclib on objective response rate (ORR) compared with placebo in patients receiving Topotecan
Measured: 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
Anti-tumor efficacy
To assess the effect of trilaciclib on duration of response (DOR) compared with placebo in patients receiving Topotecan
Measured: 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
Neutrophil-related myeloprotection efficacy
Duration of severe (CTCAE Grade 4) neutropenia in Cycle 1
Measured: From date of randomization until end of cycle 1 (each cycle is 21 days)
Neutrophil-related myeloprotection efficacy
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs
Measured: From date of randomization until end of treatment, assessed up to 52 months
Neutrophil-related myeloprotection efficacy
Occurrence of G-CSF administration
Measured: From date of randomization until end of treatment, assessed up to 52 months
RBC related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased hemoglobin laboratory values and ESA administration
Measured: From date of randomization until end of treatment, assessed up to 52 months
RBC related myeloprotection efficacy
RBC transfusions on or after Week 5 (occurrence)
Measured: From date of randomization until end of Week 5
RBC related myeloprotection efficacy
RBC transfusions on or after Week 5 (number of transfusions)
Measured: From date of randomization until end of Week 5
Platelet related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (occurrence)
Measured: From date of randomization until end of treatment, assessed up to 52 months
Platelet related myeloprotection efficacy
Occurrence of CTCAE Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions (number of transfusions)
Measured: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression
Measured: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Number of hospitalizations due to chemotherapy-induced myelosuppression
Measured: From date of randomization until end of treatment, assessed up to 52 months
Chemotherapy dosing
To assess the effects of trilaciclib on chemotherapy dosing (delays) compared with placebo when administered prior to topotecan.
Measured: From the date of randomization until end of treatment, assessed up to 52 months
Chemotherapy dosing
To assess the effects of trilaciclib on chemotherapy dosing (reductions) compared with placebo when administered prior to topotecan.
Measured: From the date of randomization until end of treatment, assessed up to 52 months
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
To assess the effects of trilaciclib administered prior to topotecan compared with placebo administered prior to topotecan on occurrence and severity of adverse events by CTCAE, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest
Measured: From the date of randomization until end of treatment, assessed up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start13 Oct 2023
- Primary completion5 Feb 2028 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pharmacosmos Clinical and non-clinical Department, Study director, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874401
- Sponsor's protocol ID
- G1T28-211
- Other IDs
- 2022-502357-34-00
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy
- ClinicalTrials.gov ID
- NCT05874401
- Acronym / sponsor ID
- G1T28-211
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- myelosuppression, ES-SCLC, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, myeloprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 5 Feb 2028 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.
Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² | Experimental | Drug: Trilaciclib, Drug: TopotecanPatients randomized 1:1 to trilaciclib. Patients receive trilaciclib (240 mg/m²) administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients receive topotecan (1.5 mg/m²) |
| Placebo + Topotecan 1.5 mg/m² | Placebo comparator | Drug: Placebo, Drug: TopotecanPatients are randomized 1:1 to placebo. Patients receive placebo administered once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients receive topotecan (1.5 mg/m²). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- History of ILD/pneumonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrilaciclibAlso: G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitorParticipants will receive intravenous trilaciclib infusion | Drug | Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² |
| PlaceboParticipants will receive intravenous placebo infusion | Drug | Placebo + Topotecan 1.5 mg/m² |
| TopotecanAlso: HycamtinParticipants will receive intravenous topotecan infusion | Drug | Placebo + Topotecan 1.5 mg/m², Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² |
Primary outcome
Overall survival (OS)
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
To assess the effect of trilaciclib on OS compared with placebo in patients receiving topotecan
16 secondary outcomes
Anti-tumor efficacy
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
Anti-tumor efficacy
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
Anti-tumor efficacy
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
Neutrophil-related myeloprotection efficacy
Time frame: From date of randomization until end of cycle 1 (each cycle is 21 days)
Neutrophil-related myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Neutrophil-related myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
RBC related myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
RBC related myeloprotection efficacy
Time frame: From date of randomization until end of Week 5
RBC related myeloprotection efficacy
Time frame: From date of randomization until end of Week 5
Platelet related myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Platelet related myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Chemotherapy dosing
Time frame: From the date of randomization until end of treatment, assessed up to 52 months
Chemotherapy dosing
Time frame: From the date of randomization until end of treatment, assessed up to 52 months
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE
Time frame: From the date of randomization until end of treatment, assessed up to 52 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pharmacosmos Clinical and non-clinical Department study director
Pharmacosmos A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trilaciclib and Topotecan in people with Extensive-stage Small-cell Lung Cancer, run by Pharmacosmos A/S at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.