Extensive-stage Small Cell Lung CancerPhase 3LUMINANCENCT04774380
Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer
A Phase 3 study testing Durvalumab, Cisplatin and Carboplatin in people with Extensive-stage Small Cell Lung Cancer, run by AstraZeneca at 35 sites in 6 countries.
Trial summary
Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Durvalumab, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 11 Nov 2021to 2 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically-documented ES-SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan (Brain metastases; must be asymptomatic or treated and stable off steroids and anticonvulsants for at least 1 month prior to study treatment)
- Participants must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide
- World Health Organization/ Eastern Cooperative Oncology Group performance status of 0 to 2 at enrollment Baseline computed tomography/ magnetic resonance imaging results of the brain, chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation
- No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-Programmed cell death-1 (PD-1), anti- Programmed cell death ligand-1 (PD-L1), and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function
- Body weight > 30 kg
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants
Who cannot join
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of Investigational medicinal product (IMP) and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Show all 21Show fewer
- Adequately treated carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis and active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus
- Any unresolved toxicity Common Terminology Criteria for Adverse Events Grade ≥ 2 from previous anticancer therapy
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Received prior systemic therapy for ES-SCLC
- Medical contraindication to platinum (cisplatin or carboplatin)-etoposide-based chemotherapy
- Any concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable
- Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed before first dose of the study medication
- Receipt of live attenuated vaccine within 30 days prior to the first dose of in IMP
- Major surgical procedure within 28 days prior to the first dose of IMP
- Participants who have received prior immunotherapy agents including anti-PD-1 or anti PD-L1
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
- Participation in another clinical study with an investigational product administered in the last 4 weeks
- Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab and 180 days after the last dose of etoposide
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
Turkey (Türkiye)12 sites
Research Site
Adapazarı, 54290
Research Site
Ankara, 06010
Research Site
Ankara, 06100
Research Site
Ankara, 06800
Research Site
Antalya, 07070
Research Site
Bursa, 16059
Research Site
Edirne, 22030
Research Site
Istanbul, 34098
Research Site
Istanbul, 34722
Research Site
Izmir, 35100
Research Site
Malatya, 44280
Research Site
Pamukkale, 20070
Germany7 sites
Research Site
Berlin, 12351
Research Site
Berlin, 13125
Research Site
Cologne, 51109
Research Site
Gauting, 82131
Research Site
Hamburg, 20251
Research Site
Jena, 07747
Research Site
Kassel, 34125
Italy7 sites
Research Site
Ancona, 60126
Research Site
Bari, 70124
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Orbassano, 10043
Research Site
Palermo, 90146
Research Site
Roma, 00168
Bulgaria5 sites
Research Site
Panagyurishte, 4500
Research Site
Rousse, 7002
Research Site
Sofia, 1303
Research Site
Sofia, 1330
Research Site
Sofia, 1407
Czechia3 sites
Research Site
Burgas, 180 81
Research Site
Olomouc, 779 00
Research Site
Ostrava, 703 00
About this study
Official title: A Phase IIIb, Single-arm, Multi-center, International Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer (LUMINANCE)
Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.
Read the detailed description
The study will be conducted in North America, Europe and Turkey.
In this single arm study participants will be treated with with durvalumab alone and concurrently with platinum-based chemotherapy and etoposide during the study period until radiological disease progression, unless there is clinical progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met, as per investigator assessment.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Durvalumab, Cisplatin, Carboplatin, Etoposide
- Keywords
- Chemotherapy, Aggressive malignancy, Programmed cell death ligand-1, Platinum-based chemotherapy
- 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.
DurvalumabDrug
Participants will receive durvalumab via IV infusion on Day 1 of each cycle.
CisplatinDrug
Participants will receive cisplatin via IV administration on Day 1 of each cycle.
CarboplatinDrug
Participants will receive carboplatin via IV administration Day 1 of each cycle.
EtoposideDrug
Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab - (cisplatin or carboplatin) - Etoposide | Experimental | Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met. Receives: Drug: Durvalumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs)
Incidence of Grade 3 or higher adverse events to evaluate safety and tolerability profile of durvalumab + Platinum (cisplatin or carboplatin) plus etoposide (EP) treatment was assessed.
Measured: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs)
Immune mediated adverse events (imAEs) were assessed to evaluate safety and tolerability profile of durvalumab + EP treatment. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action (MOA) and where there is no clear alternate etiology.
Measured: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Secondary outcomes (9)
Progression-free Survival (PFS)
Efficacy of durvalumab + EP treatment by evaluating PFS according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was assessed. The PFS is the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from Investigational medicinal product (IMP) or received another anticancer therapy prior to progression.
Measured: From first dose of study treatment until disease progression or death, up to 2.5 years.
Percentage of Participants Alive and Progression-free at 12 Months From First Date of Treatment (PFS12)
The efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1 was assessed.
Measured: From first date of study treatment until 12 months.
Objective Response Rate (ORR)
The efficacy of durvalumab + EP treatment by evaluating ORR according to RECIST 1.1 was assessed. The ORR will be assessed based on Investigator-assessed response to treatment of complete response (CR) and partial response (PR), per RECIST1.1.
Measured: From screening until disease progression or the last evaluable assessment in the absence of progression, up to 2.5 years.
Duration of Response (DoR)
The efficacy of durvalumab + EP treatment by evaluating DoR according to RECIST 1.1 was assessed. The DoR is time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.
Measured: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Percentage of Participants Remaining in Response, 12 Months After First Documented Objective Response (DoR12)
The efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1 was assessed.
Measured: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Overall Survival (OS)
Assessment of the efficacy of durvalumab + EP treatment by evaluating OS. The OS is the time from the first date of treatment until death due to any cause.
Measured: From first dose of study treatment to death, up to 2.5 years.
Percentage of Participants Alive at 12 Months From First Date of Treatment (OS12)
The efficacy of durvalumab + EP treatment by evaluating OS12 was assessed.
Measured: From first dose of study treatment till 12 months.
Number of Participants With Adverse Events and Serious Adverse Events
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events and serious adverse events were assessed.
Measured: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.
Number of Participants With Adverse Events of Special Interests
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events of special interests were assessed. An AESI is an AE of scientific and medical interest specific to understanding of the IMP. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
This includes adverse events of special/ possible interest.
Measured: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start11 Nov 2021
- Primary completion12 Jun 2023
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774380
- Sponsor's protocol ID
- D419QC00007
- Other IDs
- 2020-005537-32
- Acronym
- LUMINANCE
- Status last verified
- May 2025
- First submitted
- 25 Feb 2021
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Single-arm, Multi-center, International Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer (LUMINANCE)
- ClinicalTrials.gov ID
- NCT04774380
- Acronym / sponsor ID
- LUMINANCE / D419QC00007
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Chemotherapy, Aggressive malignancy, Programmed cell death ligand-1, Platinum-based chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.
Detailed description
The study will be conducted in North America, Europe and Turkey.
In this single arm study participants will be treated with with durvalumab alone and concurrently with platinum-based chemotherapy and etoposide during the study period until radiological disease progression, unless there is clinical progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met, as per investigator assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab - (cisplatin or carboplatin) - Etoposide | Experimental | Drug: Durvalumab, Drug: Cisplatin, Drug: Carboplatin, Drug: EtoposideParticipants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically- or cytologically-documented ES-SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan (Brain metastases; must be asymptomatic or treated and stable off steroids and anticonvulsants for at least 1 month prior to study treatment)
- Participants must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide
- World Health Organization/ Eastern Cooperative Oncology Group performance status of 0 to 2 at enrollment Baseline computed tomography/ magnetic resonance imaging results of the brain, chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation
- No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-Programmed cell death-1 (PD-1), anti- Programmed cell death ligand-1 (PD-L1), and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function
Key exclusion criteria (21 listed)
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
- History of another primary malignancy except for:
- History of leptomeningeal carcinomatosis and active primary immunodeficiency
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 |
|---|---|---|
| DurvalumabParticipants will receive durvalumab via IV infusion on Day 1 of each cycle. | Drug | Durvalumab - (cisplatin or carboplatin) - Etoposide |
| CisplatinParticipants will receive cisplatin via IV administration on Day 1 of each cycle. | Drug | Durvalumab - (cisplatin or carboplatin) - Etoposide |
| CarboplatinParticipants will receive carboplatin via IV administration Day 1 of each cycle. | Drug | Durvalumab - (cisplatin or carboplatin) - Etoposide |
| EtoposideParticipants will receive etoposide via IV administration on days 1 to 3 of each cycle. | Drug | Durvalumab - (cisplatin or carboplatin) - Etoposide |
Primary outcome
Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs)
Time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Incidence of Grade 3 or higher adverse events to evaluate safety and tolerability profile of durvalumab + Platinum (cisplatin or carboplatin) plus etoposide (EP) treatment was assessed.
Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs)
Time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.
Immune mediated adverse events (imAEs) were assessed to evaluate safety and tolerability profile of durvalumab + EP treatment. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action (MOA) and where there is no clear alternate etiology.
9 secondary outcomes
Progression-free Survival (PFS)
Time frame: From first dose of study treatment until disease progression or death, up to 2.5 years.
Percentage of Participants Alive and Progression-free at 12 Months From First Date of Treatment (PFS12)
Time frame: From first date of study treatment until 12 months.
Objective Response Rate (ORR)
Time frame: From screening until disease progression or the last evaluable assessment in the absence of progression, up to 2.5 years.
Duration of Response (DoR)
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Percentage of Participants Remaining in Response, 12 Months After First Documented Objective Response (DoR12)
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, up to 2.5 years.
Overall Survival (OS)
Time frame: From first dose of study treatment to death, up to 2.5 years.
Percentage of Participants Alive at 12 Months From First Date of Treatment (OS12)
Time frame: From first dose of study treatment till 12 months.
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.
Number of Participants With Adverse Events of Special Interests
Time frame: From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will 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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab, Cisplatin and Carboplatin in people with Extensive-stage Small Cell Lung Cancer, run by AstraZeneca at 35 sites in 6 countries.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Turkey (Türkiye), Germany, Italy, Bulgaria, Czechia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs) (time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.). The study lists 2 primary outcomes in all. 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 23 May 2025.