Relapsed Small Cell Lung CancerPhase 3NCT06496048
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
A Phase 3 study testing Lurbinectedin, Irinotecan and Topotecan in people with Relapsed Small Cell Lung Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Small Cell Lung Cancer
- What is being tested?
- Lurbinectedin, Irinotecan and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2024to 30 Jun 2028
- 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
- Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.
- Men or women ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).
- One prior line of etoposide + platinum chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of the patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
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- Chemotherapy-free interval (CTFI, i.e., the time from the last dose of first-line platinum-based chemotherapy to the occurrence of disease progression) ≥30 days.
- At least one measurable lesion (in accordance with RECIST 1.1 criteria).
- Adequate organ function as defined below:
- Hemoglobin ≥ 9.0 g/dL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 109/L, and platelet count ≥ 100 × 109/L.
- Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN.
- Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN.
- Albumin ≥ 3.0 g/dL.
- Calculated creatinine clearance (CrCL) ≥ 40 mL/min (using the Cockcroft-Gault formula, as detailed in Appendix IV).
- ≥ 3 weeks since the last anti-tumor therapy and recovery of adverse events (AEs) related to prior anti-tumor therapy to Grade ≤ 1, as judged by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) (Except for anemia; and recovery to Grade ≤ 2 for sensory neuropathy, asthenia and alopecia).
- Female patients of childbearing potential must have a negative blood or urine pregnancy test prior to enrollment, and must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 7 months after the last dose. Male patients with a female partner of childbearing potential must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 4 months after the last dose.
Who cannot join
- Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.
- Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
- Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).
- Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).
- Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and/or therapeutic) at other sites within 2 weeks prior to randomization.
- Patients with limited-stage disease who plan to receive local or regional treatment (including PCI, thoracic radiotherapy, or both) during the study (Note: patients with extensive-stage disease may receive radiotherapy during the study if they meet the requirements as described in Section 5.8.1).
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- Patients who, at the screening visit, are about to receive radiotherapy, such as for painful bone metastasis and/or risk of spinal cord compression. Patients who have a history of bone marrow and/or stem cell transplantation and allogeneic transplantation.
- Having received a live vaccine or attenuated live vaccine within 30 days before the first dose of the investigation medicinal product (inactivated vaccines are allowed).
- Concomitant diseases:
- Having unstable angina pectoris, myocardial infarction, congestive heart failure (CHF) of New York Heart Association (NYHA) class II or above, or clinically significant heart valve diseases within one year prior to screening.
- Having symptomatic arrhythmia, or arrhythmia with unstable control and requiring continuous treatment at screening.
- Patients requiring continuous oxygen inhalation within 2 weeks prior to randomization.
- Patients with confirmed or suspected diffuse interstitial lung disease or pulmonary fibrosis.
- Patients who have rapidly increasing pleural or pericardial effusion with significant symptoms, and/or need prompt local therapy within 7 days, at screening.
- Hepatic cirrhosis with the Child-Pugh score (see Appendix II for the scoring criteria) of B or C.
- Patients with Gilbert's disease.
- Patients with persistent non-neoplastic chronic liver disease (of any etiology) requiring treatment, including those with positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer ≥ 500 IU/mL, those with positive hepatitis C antibody and hepatitis C virus ribonucleic acid (HCV-RNA) titer ≥ 100 IU/mL, and those having received hepatitis-related antiviral therapy within 6 months prior to the first dose of the investigational medicinal product.
- Chronic inflammatory bowel disease or intestinal obstruction (including intestinal pseudo-obstruction, incomplete intestinal obstruction, enteroparalysis, etc.) in the past or at screening.
- Patients with uncontrolled active infection who have received systemic intravenous anti-infective therapy within 1 week prior to randomization.
- Having severe and uncured wounds, ulcers, fractures, and external drainage disposal at screening.
- Patients with confirmed or suspected invasive fungal infection within 12 weeks prior to randomization who need systemic treatment.
- Positive for human immunodeficiency virus (HIV) antibody at screening.
- Patients with prior history of malignant tumors other than SCLC, except those who have undergone radical resection more than 3 years prior to randomization and have a sustained response after treatment (e.g., cervical carcinoma in situ, basal or squamous cell skin cancer, transitional cell bladder cancer in situ, etc.).
- Any other major disease that, at the discretion of the investigator, can significantly increase the risk associated with participation in this study.
- Having a history of allergy or hypersensitivity to any of the investigational medicinal products or any of their excipients.
- Drug abuse, drug addiction or alcohol abuse (alcohol abuse is defined as drinking more than 14 units of alcohol per week within 3 months prior to signing the informed consent [1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine]).
- Pregnant or lactating women and patients of childbearing age who cannot use highly effective contraceptive methods (regardless of gender) (see Inclusion Criterion #11).
- Those who cannot fully comply with the treatment plan or comply with the study protocol, as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jilin Provincial Tumor Hospital
Jilin City
Chunjiao Wu
About this study
Official title: A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
- Conditions
- Relapsed Small Cell Lung Cancer
- Being tested
- Lurbinectedin, Irinotecan, Topotecan
- 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
Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
IrinotecanDrug
Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
LurbinectedinDrug
Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
TopotecanDrug
Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk
| Study group | Role | What they receive |
|---|---|---|
| Lurbinectedin monotherapy | Experimental | Not described Receives: Drug: Lurbinectedin |
| Lurbinectedin + Irinotecan combined therapy | Experimental | Not described Receives: Drug: Irinotecan; Drug: Lurbinectedin |
| Topotecan | Active comparator | Not described Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS will be calculated calculated from the date of randomization until the date of death or the last contact date (in which case, OS time will be censored at that date)
Measured: from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject
Secondary outcomes (4)
Progression-free survival by IRC (Independent Review Committee)
Measured: Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject
Progression-free survival by IA (Investigator Assessment)
Measured: Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject
Overall response rate by IRC
Measured: From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject
Overall response rate by IA
Measured: From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start14 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Chen, Doctor, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496048
- Sponsor's protocol ID
- LY01017/CT-CHN-302
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT06496048
- Acronym / sponsor ID
- LY01017/CT-CHN-302
- Conditions
- Relapsed Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 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.
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lurbinectedin monotherapy | Experimental | Drug: Lurbinectedin |
| Lurbinectedin + Irinotecan combined therapy | Experimental | Drug: Irinotecan, Drug: Lurbinectedin |
| Topotecan | Active comparator | Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.
- Men or women ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).
Key exclusion criteria (28 listed)
- Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.
- Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
- Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).
- Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).
- Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and/or therapeutic) at other sites within 2 weeks prior to randomization.
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: PM01183Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk) | Drug | Lurbinectedin monotherapy |
| IrinotecanIrinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk | Drug | Lurbinectedin + Irinotecan combined therapy |
| LurbinectedinLurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk) | Drug | Lurbinectedin + Irinotecan combined therapy |
| TopotecanTopotecan 1.2 mg/m² intravenously Days 1-5 q3wk | Drug | Topotecan |
Primary outcome
Overall survival (OS)
Time frame: from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject
OS will be calculated calculated from the date of randomization until the date of death or the last contact date (in which case, OS time will be censored at that date)
4 secondary outcomes
Progression-free survival by IRC (Independent Review Committee)
Time frame: Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject
Progression-free survival by IA (Investigator Assessment)
Time frame: Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject
Overall response rate by IRC
Time frame: From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject
Overall response rate by IA
Time frame: From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject
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 12 Dec 2024.
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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.
Ying Chen, Doctor principal investigator
Jilin Provincial Tumor Hospital
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 Lurbinectedin, Irinotecan and Topotecan in people with Relapsed Small Cell Lung Cancer, run by Luye Pharma Group Ltd. 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 16 inclusion and 28 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 12 Dec 2024. 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 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 Chunjiao Wu, Doctor (+86186431121295651, 2956519672@.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject). 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 12 Dec 2024.