Small Cell Lung CancerPhase 2LURBIMUNENCT05572476
Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
A Phase 2 study testing Association of lurbinectedin and durvalumab and Association of carboplatin and etoposide in people with Small Cell Lung Cancer and Platinum-Sensitive Lung Small Cell Carcinoma, run by Institut Bergonié at 1 site in France.
Trial summary
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Platinum-Sensitive Lung Small Cell Carcinoma, Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Association of lurbinectedin and durvalumab and Association of carboplatin and etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2023to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histology: confirmed diagnosis of extensive stage SCLC which failed one prior platinum-containing regimen,
- Recurrent and platinum-sensitive SCLC: defined as those patients with SCLC recurrence at least 90 days from the last dose of platinum-based chemotherapy. Definition of platinum-sensitive disease is patient with at least 90 days of progression-free duration after finishing first-line platinum-based chemotherapy
- Patients must have received as first line a combo with platinum+ etoposide + PD_L1 inhibitor
- Metastatic or unresectable locally advanced disease, not ammenable to curative therapy,
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group ≤ 1,
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- Life expectancy > 3 months,
- Patients must have measurable disease as per RECIST v1.1.
- Documented disease progression according to RECIST v1.1 before study entry,
- At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment for neoplastic disease and/or radiotherapy,
- Adequate hematological, renal, metabolic and hepatic function
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. Both women and men must agree to use a highly effective method of contraception ,
- No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, concomitant endometrial carcinoma stage IA grade 1, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
- Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the NCI-CTCAE, version 5,
- Body weight >30kg
- Voluntarily signed and dated written informed consent prior to any study specific procedure,
- Patients with a social security in compliance with the French law.
Who cannot join
- Previous treatment with lurbinectedin,
- Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 14 days before the first dose of durvalumab,
- Active or prior documented inflammatory bowel disease,
- Has an active autoimmune disease requiring systemic treatment within the past 2 years,
- Has evidence of active non-infectious pneumonitis,
- Has an active or ongoing infection requiring systemic therapy,
Show all 26Show fewer
- Currently active bacterial or fungus infection, HIV1, HIV2, hepatitis A or hepatitis B or hepatitis C infections,
- Symptomatic untreated, or steroid-requiring, or progressing central nervous system malignancy is excluded.
- Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
- Previous enrolment in the present study,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
- Has received a live vaccine within 30 days prior to the first dose of trial treatment,
- Known hypersensitivity to any involved study drug or any of its formulation components,
- Tumors not accessible for biopsy,
- Active infection including tuberculosis,
- Person under judicial protection or deprived of liberty,
- Concomitant use of strong inhibitors or inductors of cytochrome CYP3A4 taken within 21 days prior to the first dose of study drug,
- Uncontrolled symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, clinically significant valvular heart disease,
- Intermittent or continuous oxygen requirement,
- Presence of any external drainage,
- Known myopathy,
- Concomitant administration of any other antineoplastic therapy, other investigational agents, immunosuppressive therapies, Aprepitan or any other NK-1 antagonist,
- Major surgical procedure within 28 days prior to the first dose of durvalumab.
- History of allogenic organ transplantation,
- History of leptomeningeal carcinomatosis,
- QT interval corrected for heart rate using Fridericia's formula ≥470 ms
Trial locations and contacts
1 site in 1 country.
About this study
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab
Read the detailed description
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab in pre-treated patients with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen.
- Conditions
- Small Cell Lung Cancer, Platinum-Sensitive Lung Small Cell Carcinoma, Extensive-stage Small-cell Lung Cancer
- Being tested
- Association of lurbinectedin and durvalumab, Association of carboplatin and etoposide
- Keywords
- small cell lung cancer, platinum sensitive
- 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.
Association of lurbinectedin and durvalumabDrug
A treatment cycles consists of 3 weeks (i.e. 21 days). Lurbinectedin will be administered by intravenous infusion on Day 1 every 3 weeks.
Durvalumab will be administered by intravenous infusion on Day 1 every 3 weeks.
Association of carboplatin and etoposideDrug
Treatment will be administered on a 21-days cycle basis up to a maximum of 6 cycles.
Carboplatin will be administered by intravenous infusion on Day 1 every 3 weeks.
Etoposide will be administered by intravenous infusion on Day 1-3 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A: treatment by lurbinectedin and durvalumab | Experimental | Patients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of lurbinectedin and durvalumab Receives: Drug: Association of lurbinectedin and durvalumab |
| Standard Arm B: treatment by carboplatin and etoposide | Other | Patients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of carboplatin and etoposide Receives: Drug: Association of carboplatin and etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the antitumor activity of lurbinectedin combined with durvalumab
Antitumor activity will be assessed in terms of of 6-month progression-free rate (rate of complete or partial responses or stable disease more than 24 weeks, as per RECIST v1.1 criteria) after blinded centralized radiological review
Measured: 6 months
Secondary outcomes (19)
6-months objective response for experimental Arm
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Measured: 6 months
Best overall response for experimental Arm
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Measured: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for experimental Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Measured: 1 year
2-year progression-free survival for experimental Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Measured: 2 years
1-year overall survival for experimental Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 1 year
2-years overall survival for experimental Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 2 years
Safety profile for experimental Arm: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the treatment period, an expected average of 6 months
Safety profile for standard Arm: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the treatment period, an expected average of 6 months
Assessment of the antitumor activity of carboplatin combined with etoposide
Antitumor activity will be assessed in terms of of 6-month progression-free rate (rate of complete or partial responses or stable disease more than 24 weeks, as per RECIST v1.1 criteria) after blinded centralized radiological review
Measured: 6 months
6-months objective response for standard Arm
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Measured: 6 months
Best overall response for standard Arm
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Measured: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for standard Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Measured: 1 year
2-year progression-free survival for standard Arm
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first
Measured: 2 years
1-year overall survival for standard Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 1 year
2-years overall survival for standard Arm
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 2 years
Tumor immune cells levels
Levels of immune cells in tumor will be measured by immunohistochemistry
Measured: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood cytokines levels
Levels of cytokines in blood will be measured by ELISA
Measured: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood lymphocytes levels
Levels of lymphocytes in blood will be measured by flow cytometry
Measured: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood kynurenine levels
Levels of kynurenine in blood will be measured by ELISA
Measured: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startOct 2023 (estimated)
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Recruitment difficulties, decline in the incidence of the studied pathology, active competitive clinical trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized phase II study in which eligible patients will be randomized (2:1) according to two therapeutic strategies
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, PharmaMar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572476
- Sponsor's protocol ID
- IB 2022-01
- Other IDs
- 2022-001114-19
- Acronym
- LURBIMUNE
- Status last verified
- Jun 2024
- First submitted
- 5 Oct 2022
- Last updated
- 5 Jun 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05572476
- Acronym / sponsor ID
- LURBIMUNE / IB 2022-01
- Conditions
- Small Cell Lung Cancer, Platinum-Sensitive Lung Small Cell Carcinoma, Extensive-stage Small-cell Lung Cancer
- Keywords
- small cell lung cancer, platinum sensitive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties, decline in the incidence of the studied pathology, active competitive clinical trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- AstraZeneca, PharmaMar
- Study start
- Oct 2023 (estimated)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Oct 2022 (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, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab
Detailed description
Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab in pre-treated patients with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized phase II study in which eligible patients will be randomized (2:1) according to two therapeutic strategies
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A: treatment by lurbinectedin and durvalumab | Experimental | Drug: Association of lurbinectedin and durvalumabPatients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of lurbinectedin and durvalumab |
| Standard Arm B: treatment by carboplatin and etoposide | Other | Drug: Association of carboplatin and etoposidePatients with with platinum sensitive extensive stage small-cell lung cancer (SCLC) which failed one prior platinum-containing regimen will be treated by the association of carboplatin and etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histology: confirmed diagnosis of extensive stage SCLC which failed one prior platinum-containing regimen,
- Recurrent and platinum-sensitive SCLC: defined as those patients with SCLC recurrence at least 90 days from the last dose of platinum-based chemotherapy. Definition of platinum-sensitive disease is patient with at least 90 days of progression-free duration after finishing first-line platinum-based chemotherapy
- Patients must have received as first line a combo with platinum+ etoposide + PD_L1 inhibitor
- Metastatic or unresectable locally advanced disease, not ammenable to curative therapy,
- Age ≥ 18 years,
Key exclusion criteria (26 listed)
- Previous treatment with lurbinectedin,
- Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 14 days before the first dose of durvalumab,
- Active or prior documented inflammatory bowel disease,
- Has an active autoimmune disease requiring systemic treatment within the past 2 years,
- Has evidence of active non-infectious pneumonitis,
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 |
|---|---|---|
| Association of lurbinectedin and durvalumabA treatment cycles consists of 3 weeks (i.e. 21 days). Lurbinectedin will be administered by intravenous infusion on Day 1 every 3 weeks. Durvalumab will be administered by intravenous infusion on Day 1 every 3 weeks. | Drug | Experimental Arm A: treatment by lurbinectedin and durvalumab |
| Association of carboplatin and etoposideTreatment will be administered on a 21-days cycle basis up to a maximum of 6 cycles. Carboplatin will be administered by intravenous infusion on Day 1 every 3 weeks. Etoposide will be administered by intravenous infusion on Day 1-3 every 3 weeks | Drug | Standard Arm B: treatment by carboplatin and etoposide |
Primary outcome
Assessment of the antitumor activity of lurbinectedin combined with durvalumab
Time frame: 6 months
Antitumor activity will be assessed in terms of of 6-month progression-free rate (rate of complete or partial responses or stable disease more than 24 weeks, as per RECIST v1.1 criteria) after blinded centralized radiological review
19 secondary outcomes
6-months objective response for experimental Arm
Time frame: 6 months
Best overall response for experimental Arm
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for experimental Arm
Time frame: 1 year
2-year progression-free survival for experimental Arm
Time frame: 2 years
1-year overall survival for experimental Arm
Time frame: 1 year
2-years overall survival for experimental Arm
Time frame: 2 years
Safety profile for experimental Arm: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile for standard Arm: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Assessment of the antitumor activity of carboplatin combined with etoposide
Time frame: 6 months
6-months objective response for standard Arm
Time frame: 6 months
Best overall response for standard Arm
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival for standard Arm
Time frame: 1 year
2-year progression-free survival for standard Arm
Time frame: 2 years
1-year overall survival for standard Arm
Time frame: 1 year
2-years overall survival for standard Arm
Time frame: 2 years
Tumor immune cells levels
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood cytokines levels
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood lymphocytes levels
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Blood kynurenine levels
Time frame: before treatment onset, at cycle 2 days 1, cycle 3 day 1 and at progression (each cycle is 21 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Association of lurbinectedin and durvalumab and Association of carboplatin and etoposide in people with Small Cell Lung Cancer and Platinum-Sensitive Lung Small Cell Carcinoma, run by Institut Bergonié at 1 site in France.
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 17 inclusion and 26 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: withdrawn, as of the sponsor's last update on 5 Jun 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of the antitumor activity of lurbinectedin combined with durvalumab (time frame: 6 months). 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 5 Jun 2024.