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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 91 |
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Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer
Phase 3 trial testing Durvalumab in Extensive-stage Small Cell Lung Cancer in 152 participants. Completed in 2 January 2025.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 152 |
| Start date | 11 November 2021 |
| Primary completion | 12 June 2023 |
| Estimated completion | 2 January 2025 |
| Sites | 35 locations across Italy, Germany, Canada, Bulgaria, Turkey (Türkiye), Czechia |
AstraZeneca — full company profile →
Adults 18 to 130, any sex, with Extensive-stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 91 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 22 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 6.3 | 5.75 – 6.47 |
The efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1 was assessed.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 15.0 | 9.76 – 21.21 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 66.4 | 58.3 – 73.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 5.2 | 5.03 – 5.59 |
The efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1 was assessed.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 19.8 | 12.70 – 28.06 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 16.4 | 12.45 – 18.73 |
The efficacy of durvalumab + EP treatment by evaluating OS12 was assessed.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 59.8 | 51.00 – 67.55 |
To evaluate safety and tolerability profile of durvalumab + EP treatment, adverse events and serious adverse events were assessed.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 142 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 109 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 85 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 59 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 15 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab+EP | 82 |
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.
| Reaction | System | Durvalumab+EP |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Platelet count decreased | Investigations | — |
| Sepsis | Infections and infestations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Abdominal infection | Infections and infestations | — |
| COVID-19 pneumonia | Infections and infestations | — |
| Lower respiratory tract infection | Infections and infestations | — |
| Postoperative wound infection | Infections and infestations | — |
| Tooth abscess | Infections and infestations | — |
| Urinary tract infection bacterial | Infections and infestations | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Acidosis | Metabolism and nutrition disorders | — |
| Hypernatraemia | Metabolism and nutrition disorders | — |
| Hyperphosphataemia | Metabolism and nutrition disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Reaction | System | Durvalumab+EP |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Fatigue | General disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Blood creatinine increased | Investigations | — |
| White blood cell count decreased | Investigations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| COVID-19 | Infections and infestations | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Asthenia | General disorders | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Amylase increased | Investigations | — |
| Blood lactate dehydrogenase increased | Investigations | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Weight decreased | Investigations | — |
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.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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