Limited Stage Small Cell Lung CancerPhase 3NCT07473128
Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer
A Phase 3 study testing Trilaciclib and Saline (0.9% NaCl) in people with Limited Stage Small Cell Lung Cancer, run by Pharmacosmos A/S at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer
- What is being tested?
- Trilaciclib and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 31 Oct 2027
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pharmacosmos Investigational Site
Oakland, California, 48073
Pharmacosmos A/S Clinical and non-clinical research, +4559485959, info@pharmacosmos.com
About this study
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
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.
- Conditions
- Limited Stage Small Cell Lung Cancer
- Being tested
- Trilaciclib, Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Intravenous infusion
Saline (0.9% NaCl)Drug
Also called dextrose
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib | Experimental | Receives trilaciclib Receives: Drug: Trilaciclib |
| Placebo | Placebo comparator | Receives placebo Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare trilaciclib to placebo on prevention of myelosuppression
Duration and occurrence of severe neutropenia
Measured: From enrollment and 4 months after
Secondary outcomes (5)
Number of all-cause chemotherapy dose reductions
Measured: From enrollment and 4 months after
Occurrence of granulocyte colony-stimulating factor (G-CSF) administration
Measured: From enrollment and 4 months after
Number of hospitalizations due to myelosuppression or sepsis
Measured: From enrollment and 4 months after
Number of febrile neutropenia
Measured: From enrollment and 4 months after
Occurrence of red blood cell (RBC) transfusions
Measured: From enrollment and 4 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startSep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473128
- Sponsor's protocol ID
- LS-SCLC-01
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07473128
- Acronym / sponsor ID
- LS-SCLC-01
- Conditions
- Limited Stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib | Experimental | Drug: TrilaciclibReceives trilaciclib |
| Placebo | Placebo comparator | Drug: Saline (0.9% NaCl)Receives placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| TrilaciclibIntravenous infusion | Drug | Trilaciclib |
| Saline (0.9% NaCl)Also: dextroseIntravenous infusion | Drug | Placebo |
Primary outcome
To Compare trilaciclib to placebo on prevention of myelosuppression
Time frame: From enrollment and 4 months after
Duration and occurrence of severe neutropenia
5 secondary outcomes
Number of all-cause chemotherapy dose reductions
Time frame: From enrollment and 4 months after
Occurrence of granulocyte colony-stimulating factor (G-CSF) administration
Time frame: From enrollment and 4 months after
Number of hospitalizations due to myelosuppression or sepsis
Time frame: From enrollment and 4 months after
Number of febrile neutropenia
Time frame: From enrollment and 4 months after
Occurrence of red blood cell (RBC) transfusions
Time frame: From enrollment and 4 months after
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trilaciclib and Saline (0.9% NaCl) in people with Limited Stage Small Cell Lung Cancer, run by Pharmacosmos A/S at 1 site in United States.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Pharmacosmos A/S Clinical and non-clinical research (+4559485959, info@pharmacosmos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare trilaciclib to placebo on prevention of myelosuppression (time frame: From enrollment and 4 months after). 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 2 Oct 2026.