A Phase 4 interventional study of Trilaciclib and Placebo in Extensive-stage Small-cell Lung Cancer, sponsored by Pharmacosmos A/S. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Pharmacosmos A/S · Phase 4, Interventional, and Treatment
Among 141 studies in Small Cell Lung Carcinoma with a site in Spain — 39 open to participants now, 65 under way, 23 of them phase 3. Small Cell Lung Carcinoma · Spain.
Among the 141 studies in Small Cell Lung Carcinoma with a site in Spain, this one is the 47th largest by planned enrollment of the 135 interventional ones that give a count, is one of 10 that started in 2023, is the only one in phase 4, reaches primary completion later than 28 of the 64 other live ones, and was the 101st registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 302 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →39 of the 141 studies in Small Cell Lung Carcinoma with a site in Spain are open now.
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 264 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 67 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →141 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 61 · Phase 2 59 · Phase 3 41 · Phase 4 1
First in 1998; this study’s year is marked. 10 started in 2023.
Median enrollment 184 across the 135 interventional studies, 632 across the 6 observational. Of the 76 that completed or were terminated, 41 (54%) have results posted.
127 of 141 have an industry lead sponsor. The 10 most frequent:
Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Pharmacosmos A/S has 2 studies filed under Small Cell Lung Carcinoma — fewer than ten, so there is no comparison to draw.
11 of the studies in Small Cell Lung Carcinoma with a site in Spain that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06095583Phase 3Shanghai Junshi Bioscience Co., Ltd.Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) | 2027-07-31 |
| NCT06646276Phase 3Bristol-Myers SquibbA Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). | 2027-08-17 |
| NCT04624204Phase 3Merck Sharp & Dohme LLCPlacebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) | 2027-10-28 |
| NCT07099898Phase 3GlaxoSmithKlineA Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301] | 2027-11-05 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
Among the 141 studies in Small Cell Lung Carcinoma with a site in Spain, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Trilaciclib · Drug: Topotecan
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).
Drug: Placebo · Drug: Topotecan
Participants will receive intravenous trilaciclib infusion
Also known as: G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor
Participants will receive intravenous placebo infusion
Participants will receive intravenous topotecan infusion
Also known as: Hycamtin
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
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
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
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
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)
Neutrophil-related myeloprotection efficacy
Occurrence of severe (CTCAE Grade 4) neutropenia and febrile neutropenia AEs
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Neutrophil-related myeloprotection efficacy
Occurrence of G-CSF administration
Time frame: 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
Time frame: 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)
Time frame: From date of randomization until end of Week 5
RBC related myeloprotection efficacy
RBC transfusions on or after Week 5 (number of transfusions)
Time frame: 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)
Time frame: 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)
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Occurrence of hospitalizations due to chemotherapy-induced myelosuppression
Time frame: From date of randomization until end of treatment, assessed up to 52 months
Myeloprotection efficacy
Number of hospitalizations due to chemotherapy-induced myelosuppression
Time frame: 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.
Time frame: 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.
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
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
Time frame: From the date of randomization until end of treatment, assessed up to 52 months
Started Oct 2023 (actual). Primary completion is estimated for Feb 2028, 51 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: primary completion Oct 2027 → Feb 2028 and completion Oct 2027 → Feb 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trilaciclib