A Phase 2 interventional study of Lurbinectedin and Durvalumab in Extensive-stage Small-cell Lung Cancer, sponsored by Jazz Pharmaceuticals. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Jazz Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.
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 50 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Jazz Pharmaceuticals is the lead sponsor of 173 studies on the registry; 18 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 32 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Durvalumab taken in combination with lurbinectedin in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen.
Drug: Lurbinectedin · Drug: Durvalumab
Administered by intravenous (IV) infusion
Also known as: Zepzelca
Administered by intravenous (IV) infusion
Also known as: Imfinzi
Investigator assessed PFS rate
Progression Free Survival (PFS) rate is the proportion of participants who have not experienced disease progression (as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) or death from any cause
Time frame: 6 months
Investigator assessed PFS
PFS is defined as the time from the start of maintenance treatment until the first documentation of disease progression (as determined by the investigator according to RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Investigator-assessed confirmed ORR
Confirmed Objective Response Rate (ORR) is the proportion of participants with Complete Response (CR) or Partial Response (PR) on 2 consecutive occasions ≥ 4 weeks apart, after the start of maintenance treatment, as determined by the investigator according to RECIST v1.1.
Time frame: Up to 2 years
Number of participants requiring dose modification
Time frame: Up to 2 years
Number of participants requiring discontinuations of any component of the combination therapy
Time frame: Up to 2 years
Plasma Concentrations of lurbinectedin
Time frame: Up to 3 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 or higher
Time frame: First dose to 90 days after last dose (Up to 2 years)
Plan to share: Yes — In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
Data sharing details ↗ · www.jazzpharma.com
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2029, 33 months after the start.
Of 53 industry-sponsored phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's planned 33 months is close to that.
Counting every sponsor, half of 203 studies reached it within 47 months; a quarter within 29 and three quarters within 84.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: start Nov 2026 → Oct 2026, primary completion Jan 2028 → Aug 2029 and completion Apr 2028 → Nov 2029.
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 ↗
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Studies of the drugs tested here: PM 01183 · Durvalumab