Last reviewed · How we verify
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Phase 3 trial testing Durvalumab in Small Cell Lung Carcinoma Extensive Disease in 101 participants. Completed in 21 June 2023.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 16 December 2020 |
| Primary completion | 21 June 2023 |
| Estimated completion | 21 June 2023 |
| Sites | 34 locations across Spain |
AstraZeneca — full company profile →
18 and older, any sex, with Small Cell Lung Carcinoma Extensive Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 77 | |
| Experimental Arm | 24 |
Patients with immune-mediated adverse events (imAE) per patient
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 38 | |
| Experimental Arm | 63 |
PFS: Defined as 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 patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 6.1 | 5.2 – 6.9 |
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 54.5 | 44.7 – 64.2 |
DoR: Defined as the 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 |
|---|---|---|
| Experimental Arm | 5.6 | 4.7 – 6.5 |
TTD: Defined as the time from the first date of treatment until the end of treatment date.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 6.2 | 4.5 – 9.9 |
OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 9.6 | 7.8 – 11.3 |
Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 53.0 | 43.2 – 62.8 |
Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 21.0 | 13.0 – 29.0 |
Percentage of responders remaining alive without disease progression at 12 months after first response.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 35.7 | 23.0 – 48.4 |
Percentage of participants remaining alive at 6 months after initiation of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 75.2 | 66.8 – 83.6 |
Percentage of participants remaining alive at 12 months after initiation of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Arm | 40.7 | 31.1 – 50.3 |
Time frame: During study treatment, until disease progression (median 6 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Experimental Arm |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Pneumonia | Infections and infestations | — |
| Pyrexia | General disorders | — |
| Sepsis | Infections and infestations | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Pancytopenia | Blood and lymphatic system disorders | — |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| COVID-19 pneumonia | Infections and infestations | — |
| Seizure | Nervous system disorders | — |
| Superior vena cava syndrome | Vascular disorders | — |
| Atrial flutter | Cardiac disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Cardio-respiratory arrest | Cardiac disorders | — |
| Diplopia | Eye disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Haematemesis | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Bile duct stone | Hepatobiliary disorders | — |
| Hepatitis | Hepatobiliary disorders | — |
| Bronchitis | Infections and infestations | — |
| COVID-19 | Infections and infestations | — |
| Reaction | System | Experimental Arm |
|---|---|---|
| Asthenia | General disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Pyrexia | General disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Platelet count decreased | Investigations | — |
| Mucosal inflammation | General disorders | — |
| Respiratory tract infection | Infections and infestations | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Oedema peripheral | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Amylase increased | Investigations | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Fatigue | General disorders | — |
| Illness | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| COVID-19 | Infections and infestations | — |
| Dizziness | Nervous system disorders | — |
Most-reported serious reactions: Febrile neutropenia, Pneumonia, Pyrexia, Sepsis, Dyspnoea, Hyponatraemia, Pneumonitis, Neutropenia.
Data from ClinicalTrials.gov NCT04712903 adverse events section.
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.
6 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT04712903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing