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NCT04774380: LUMINANCE

Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

Completed Phase 3 Results posted Last updated 23 May 2025
What this trial tests

Phase 3 trial testing Durvalumab in Extensive-stage Small Cell Lung Cancer in 152 participants. Completed in 2 January 2025.

Timeline
11 November 2021
Primary endpoint
12 June 2023
2 January 2025

Quick facts

Lead sponsorAstraZeneca
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment152
Start date11 November 2021
Primary completion12 June 2023
Estimated completion2 January 2025
Sites35 locations across Italy, Germany, Canada, Bulgaria, Turkey (Türkiye), Czechia

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Extensive-stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs) Primary · 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.

GroupValue95% CI
Durvalumab+EP91
Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs) Primary · 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.

GroupValue95% CI
Durvalumab+EP22
Progression-free Survival (PFS) Secondary · From first dose of study treatment until disease progression or death, up to 2.5 years.

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.

GroupValue95% CI
Durvalumab+EP6.35.75 – 6.47
Percentage of Participants Alive and Progression-free at 12 Months From First Date of Treatment (PFS12) Secondary · From first date of study treatment until 12 months.

The efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1 was assessed.

GroupValue95% CI
Durvalumab+EP15.09.76 – 21.21
Objective Response Rate (ORR) Secondary · From screening until disease progression or the last evaluable assessment in the absence of progression, up to 2.5 years.

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.

GroupValue95% CI
Durvalumab+EP66.458.3 – 73.9
Duration of Response (DoR) Secondary · 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.

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.

GroupValue95% CI
Durvalumab+EP5.25.03 – 5.59
Percentage of Participants Remaining in Response, 12 Months After First Documented Objective Response (DoR12) Secondary · 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.

The efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1 was assessed.

GroupValue95% CI
Durvalumab+EP19.812.70 – 28.06
Overall Survival (OS) Secondary · From first dose of study treatment to death, up to 2.5 years.

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.

GroupValue95% CI
Durvalumab+EP16.412.45 – 18.73
Percentage of Participants Alive at 12 Months From First Date of Treatment (OS12) Secondary · From first dose of study treatment till 12 months.

The efficacy of durvalumab + EP treatment by evaluating OS12 was assessed.

GroupValue95% CI
Durvalumab+EP59.851.00 – 67.55
Number of Participants With Adverse Events and Serious Adverse Events Secondary · From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.

To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events and serious adverse events were assessed.

Any Adverse event (AE)
GroupValue95% CI
Durvalumab+EP142
Any AE possibly related to any treatment
GroupValue95% CI
Durvalumab+EP109
Any AE of maximum CTCAE grade 3 or grade 4
GroupValue95% CI
Durvalumab+EP85
Any AE of maximum CTCAE grade 3 or grade 4, possibly related to any treatment
GroupValue95% CI
Durvalumab+EP59
Any AE with outcome of death
GroupValue95% CI
Durvalumab+EP15
Any AE with outcome of death, possibly related to any treatment
GroupValue95% CI
Durvalumab+EP4
Any AE with outcome of death, possibly related to durvalumab
GroupValue95% CI
Durvalumab+EP0
Any AE with outcome of death, possibly related to EP
GroupValue95% CI
Durvalumab+EP4
Number of Participants With Adverse Events of Special Interests Secondary · From first dose of study treatment until 90 days after discontinuation, up to 2.5 years.

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.

GroupValue95% CI
Durvalumab+EP82

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study treatment until 90 days after treatment discontinuation, up to 2.5 years.. Reporting threshold: 0.03%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Durvalumab+EP
Serious: 52/152 (34%)
Deaths: 85/152

Serious adverse events (65 terms)

ReactionSystemDurvalumab+EP
PneumoniaInfections and infestations
HyponatraemiaMetabolism and nutrition disorders
Acute kidney injuryRenal and urinary disorders
AnaemiaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
HyperglycaemiaMetabolism and nutrition disorders
Abdominal pain upperGastrointestinal disorders
Platelet count decreasedInvestigations
SepsisInfections and infestations
Febrile neutropeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
ConstipationGastrointestinal disorders
Abdominal infectionInfections and infestations
COVID-19 pneumoniaInfections and infestations
Lower respiratory tract infectionInfections and infestations
Postoperative wound infectionInfections and infestations
Tooth abscessInfections and infestations
Urinary tract infection bacterialInfections and infestations
NeutropeniaBlood and lymphatic system disorders
AcidosisMetabolism and nutrition disorders
HypernatraemiaMetabolism and nutrition disorders
HyperphosphataemiaMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
Other adverse events (57 terms — click to expand)

ReactionSystemDurvalumab+EP
AnaemiaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
ConstipationGastrointestinal disorders
ThrombocytopeniaBlood and lymphatic system disorders
FatigueGeneral disorders
AlopeciaSkin and subcutaneous tissue disorders
LeukopeniaBlood and lymphatic system disorders
HypomagnesaemiaMetabolism and nutrition disorders
HyperthyroidismEndocrine disorders
HypothyroidismEndocrine disorders
Blood creatinine increasedInvestigations
White blood cell count decreasedInvestigations
HyponatraemiaMetabolism and nutrition disorders
CoughRespiratory, thoracic and mediastinal disorders
Gamma-glutamyltransferase increasedInvestigations
Neutrophil count decreasedInvestigations
Aspartate aminotransferase increasedInvestigations
Upper respiratory tract infectionInfections and infestations
Decreased appetiteMetabolism and nutrition disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
PyrexiaGeneral disorders
Alanine aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
HeadacheNervous system disorders
COVID-19Infections and infestations
HypoalbuminaemiaMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
AstheniaGeneral disorders
Blood alkaline phosphatase increasedInvestigations
DyspepsiaGastrointestinal disorders
Amylase increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
HypocalcaemiaMetabolism and nutrition disorders
DizzinessNervous system disorders
StomatitisGastrointestinal disorders
VomitingGastrointestinal disorders
Weight decreasedInvestigations

Most-reported serious reactions: Pneumonia, Hyponatraemia, Acute kidney injury, Anaemia, Leukopenia, Hyperglycaemia, Abdominal pain upper, Platelet count decreased.

Data from ClinicalTrials.gov NCT04774380 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Platinum and Palladium Complexes as Promising Sources for Antitumor Treatments.
    Czarnomysy R, Radomska D, Szewczyk OK, Roszczenko P, et al · · 2021 · cited 47× · PMID 34361037 · DOI 10.3390/ijms22158271
  2. Synergistic Action of Immunotherapy and Nanotherapy against Cancer Patients Infected with SARS-CoV-2 and the Use of Artificial Intelligence.
    Gupta T, Debele TA, Wei YF, Gupta A, et al · · 2022 · cited 1× · PMID 35008377 · DOI 10.3390/cancers14010213

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

Other recruiting trials for Extensive-stage Small Cell Lung Cancer

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04774380.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing