Small Cell Lung CarcinomaPhase 2NCT06501976
An Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment
A Phase 2 study testing Lurbinectedin and Radiation Therapy in people with Small Cell Lung Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat SCLC with Single-lesion progression after first course treatment. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Lurbinectedin and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to Jun 2027
- Phase
- Phase 2
- 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
- Has fully understood this study, voluntarily signed a written informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
- Age ≥ 18 years, Male/female participants;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2;
- With pathologically confirmed diagnosis of SCLC,with Single-lesion progression after first course treatment;
- Has sufficient bone marrow, liver, kidney, and metabolic function, i.e., the functional levels of organs meet the following requirements:
- Platelets (PLT) ≥ 100×10^9/L;
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- Hemoglobin (Hb) ≥ 90 g/L;
- Absolute neutrophil (ANC) ≥ 2.0×10^9/L;
- Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0× upper limit of normal (ULN);
- Alkaline phosphatase (ALP) ≤ 5×ULN;
- Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;
- Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
- Creatine phosphokinase (CPK) ≤ 2.5×ULN;
- Albumin ≥ 3.0 g/dL.
- A female of childbearing potential (FCBP) must have a negative serum pregnancy test prior to study entry. Woman of childbearing potential (WOCBP) must use adequate contraception during the test drug treatment period and for 6 months after the final dose. Male patients (with partners of WOCBP) must use adequate contraception for the duration of study participation, and 4 months after completion of administration.
Who cannot join
- With concurrent brain metastasis, a history of spinal cord compression, or meningeal metastasis;
- Patients with obstructive atelectasis, superior vena cava syndrome requiring surgical/ endoscopic/ interventional treatment; suspected or confirmed pulmonary embolism patients; those with uncontrollable large amounts of pleural effusion, ascites, or pericardial effusion;
- Patients known to be allergic to any component of the test drug;
- Pregnancy or breastfeeding or WOCBP who has a positive serum pregnancy test;
- Comorbidities Requirements:
- Has unstable angina, myocardial infarction, congestive heart failure (CHF) classified as New York Heart Association (NYHA) II or higher, or other clinically significant cardiovascular diseases currently or within the past year prior to screening;
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- Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
- Patients with severe arrhythmias requiring medication;
- Patients with active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks prior to administration;
- Patients with evidence of bleeding tendencies or coagulation disorders;
- Patients with other significant diseases judged unsuitable for entry by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat SCLC with Single-lesion progression after first course treatment. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.
Read the detailed description
PRIMARY OBJECTIVE:
To describe the safety in terms of radiation therapy (RT) in combination with lurbinectedin in SCLC patients with Single-lesion progression after first course treatment.
SECONDARY OBJECTIVES:
To evaluate the preliminary efficacy of RT plus lurbinectedin, as assessed by Progression free survival (PFS) and Overall survival (OS).
OUTLINE:
Patients receive 2 cycles of lurbinectedin combined with radiotherapy followed by lurbinectedin alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. G-CSF（Granulocyte Colony-Stimulating Factor） will be used for prophylaxis.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Lurbinectedin, Radiation Therapy
- Keywords
- Lurbinectedin, radiotherapy
- 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.
LurbinectedinDrug
Also called PM01183, Zepzelca
2.6 mg/m2 , Given IV, every 21 days
Radiation TherapyRadiation
Thoracic radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment: Lurbinectedin combined with Radiotherapy | Experimental | Patients receive 2 cycles of lurbinectedin 3.2 mg/m2 combined with radiotherapy followed by lurbinectedin 3.2 mg/m2 alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. Receives: Drug: Lurbinectedin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events of radio therapy with lurbinectedin
≥grade 4 treatment related adverse events within 30 days of final RT fraction; Any treatment related adverse events leading to dose delays or reductions of lurbinectedin; Any treatment related serious adverse events .
Measured: 30 days following treatment completion
Secondary outcomes (2)
Progression free survival (PFS)
PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated.
Measured: From protocol treatment initiation to disease progression or death, assessed up to 24 months
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated.
Measured: From treatment initiation to death, , assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start31 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan Bi, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501976
- Sponsor's protocol ID
- NCC4493
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment
- ClinicalTrials.gov ID
- NCT06501976
- Acronym / sponsor ID
- NCC4493
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Lurbinectedin, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jul 2024 (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 exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat SCLC with Single-lesion progression after first course treatment. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.
Detailed description
PRIMARY OBJECTIVE:
To describe the safety in terms of radiation therapy (RT) in combination with lurbinectedin in SCLC patients with Single-lesion progression after first course treatment.
SECONDARY OBJECTIVES:
To evaluate the preliminary efficacy of RT plus lurbinectedin, as assessed by Progression free survival (PFS) and Overall survival (OS).
OUTLINE:
Patients receive 2 cycles of lurbinectedin combined with radiotherapy followed by lurbinectedin alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. G-CSF（Granulocyte Colony-Stimulating Factor） will be used for prophylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment: Lurbinectedin combined with Radiotherapy | Experimental | Drug: Lurbinectedin, Radiation: Radiation TherapyPatients receive 2 cycles of lurbinectedin 3.2 mg/m2 combined with radiotherapy followed by lurbinectedin 3.2 mg/m2 alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Has fully understood this study, voluntarily signed a written informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
- Age ≥ 18 years, Male/female participants;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2;
- With pathologically confirmed diagnosis of SCLC,with Single-lesion progression after first course treatment;
- Has sufficient bone marrow, liver, kidney, and metabolic function, i.e., the functional levels of organs meet the following requirements:
Key exclusion criteria (11 listed)
- With concurrent brain metastasis, a history of spinal cord compression, or meningeal metastasis;
- Patients with obstructive atelectasis, superior vena cava syndrome requiring surgical/ endoscopic/ interventional treatment; suspected or confirmed pulmonary embolism patients; those with uncontrollable large amounts of pleural effusion, ascites, or pericardial effusion;
- Patients known to be allergic to any component of the test drug;
- Pregnancy or breastfeeding or WOCBP who has a positive serum pregnancy test;
- Comorbidities Requirements:
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 |
|---|---|---|
| LurbinectedinAlso: PM01183, Zepzelca2.6 mg/m2 , Given IV, every 21 days | Drug | Experimental Treatment: Lurbinectedin combined with Radiotherapy |
| Radiation TherapyThoracic radiotherapy | Radiation | Experimental Treatment: Lurbinectedin combined with Radiotherapy |
Primary outcome
Incidence of adverse events of radio therapy with lurbinectedin
Time frame: 30 days following treatment completion
≥grade 4 treatment related adverse events within 30 days of final RT fraction; Any treatment related adverse events leading to dose delays or reductions of lurbinectedin; Any treatment related serious adverse events .
2 secondary outcomes
Progression free survival (PFS)
Time frame: From protocol treatment initiation to disease progression or death, assessed up to 24 months
Overall survival (OS)
Time frame: From treatment initiation to death, , assessed up to 24 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 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
Nan Bi, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lurbinectedin and Radiation Therapy in people with Small Cell Lung Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 15 inclusion and 11 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 16 Jun 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 China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of adverse events of radio therapy with lurbinectedin (time frame: 30 days following treatment completion). 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 16 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.