A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.
NCT ID: NCT05683977
Last Updated: 2025-11-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
254 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-11-14
Study Completion Date
2027-03-01
Brief Summary
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Small cell lung cancer (SCLC), characterized by rapid proliferation, high growth fraction and early development of metastases, is the most aggressive form of lung cancer. In 2021, an estimated 2.3 million people around the world are diagnosed with lung cancer. In France, in 2018, with 46 363 new cases and 33 117 deaths, lung cancer represented the second most common cancer and the first cause of death from cancer. Among those, SCLC represented 10,8% of all new lung diagnosis, and about two thirds presented at the extensive stage (ES-SCLC).
Since last three decades, standard treatment in ES-SCLC is based on combination chemotherapy with a platinum agent and etoposide in first-line with or without concurrent radiation therapy. Then, the second-line of treatment is topotecan, with few results in terms of response rates and survival rate. However, the emergence of immune checkpoint inhibitors targeting the programmed cell death receptor-1 (PD-1)/PD-ligand 1 (PD-L1) pathway, having an important role in immune regulation became an alternative method in the management and care of disease. Indeed, recent studies have shown an overall survival (OS) benefit for patients with ES-SCLC treated in first line with a combination of platinum-etoposide and immune checkpoint inhibitors. Atezolizumab (Tecentriq®, Roche) and durvalumab (Imfinzi®, AstraZeneca), two anti-Programmed death-ligand 1 (PD-L1) antibodies, delivered positive phase III results, respectively through the Impower-133 and CASPIAN studies, and were granted European market authorisations.
Durvalumab is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with ES-SCLC. On March 10, 2020 French health authorities allowed durvalumab utilization in this setting through a national "early access program" (Autorisation Temporaire d'Utilisation "de cohorte" - ATUc), thus preceding the European market authorization (August 28, 2020). Since 2020 October 1st, durvalumab is used as a post ATU treatment. Since 2020, French AURA treatment guidelines for SCLC have referenced durvalumab in combination with chemotherapy as a first-line treatment option for patients with ES-SCLC.
Whereas the safety and efficacy of the durvalumab have been evaluated in a clinical trial, data are required to further evaluate the use of durvalumab in real-life condition and in less selected population than in clinical trials.
Since last three decades, standard treatment in ES-SCLC is based on combination chemotherapy with a platinum agent and etoposide in first-line with or without concurrent radiation therapy. Then, the second-line of treatment is topotecan, with few results in terms of response rates and survival rate. However, the emergence of immune checkpoint inhibitors targeting the programmed cell death receptor-1 (PD-1)/PD-ligand 1 (PD-L1) pathway, having an important role in immune regulation became an alternative method in the management and care of disease. Indeed, recent studies have shown an overall survival (OS) benefit for patients with ES-SCLC treated in first line with a combination of platinum-etoposide and immune checkpoint inhibitors. Atezolizumab (Tecentriq®, Roche) and durvalumab (Imfinzi®, AstraZeneca), two anti-Programmed death-ligand 1 (PD-L1) antibodies, delivered positive phase III results, respectively through the Impower-133 and CASPIAN studies, and were granted European market authorisations.
Durvalumab is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with ES-SCLC. On March 10, 2020 French health authorities allowed durvalumab utilization in this setting through a national "early access program" (Autorisation Temporaire d'Utilisation "de cohorte" - ATUc), thus preceding the European market authorization (August 28, 2020). Since 2020 October 1st, durvalumab is used as a post ATU treatment. Since 2020, French AURA treatment guidelines for SCLC have referenced durvalumab in combination with chemotherapy as a first-line treatment option for patients with ES-SCLC.
Whereas the safety and efficacy of the durvalumab have been evaluated in a clinical trial, data are required to further evaluate the use of durvalumab in real-life condition and in less selected population than in clinical trials.
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Detailed Description
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Small cell lung cancer (SCLC), characterized by rapid proliferation, high growth fraction and early development of metastases, is the most aggressive form of lung cancer. SCLC is a relatively rare but really aggressive tumour accounting for 10-15% of all newly diagnosed lung cancer. In 2021, an estimated 2.3 million people around the world are diagnosed with lung cancer . In France, in 2018, with 46 363 new cases and 33 117 deaths, lung cancer represented the second most common cancer and the first cause of death from cancer. Among those, SCLC represented 10,8% of all new lung diagnosis, and about two thirds presented at the extensive stage (ES-SCLC).
Between 2010 and 2018, the incidence rate increased of 0,3 % per year in men. In contrast, from 1990 to 2018, the incidence increased more dramatically among women, with an increase of 5% in average per year. The 5-year survival rate for all people with all types of lung cancer is 21%. The 5-year survival rate is 17% and 24% for men and women, respectively. For SCLC, due to the rapid proliferation and high growth fraction associated to early development of metastases in the disease course (most commonly to the brain, liver, or bone), the 5-year survival rate is low at 10%. Therefore, SCLC is the most lethal lung cancer subtype. Most cases of SCLC develop in patients aged 60-80 years and the estimated overall death rate is 25,000-30,000 per year in United States. More than 90% of patients with SCLC are elderly and have heavy smoking histories.
SCLC is defined histologically as "a malignant epithelial tumour consisting of small cells with scant cytoplasm, ill-defined cell borders, finely granular nuclear chromatin, and absent or inconspicuous nucleoli", assessed by imaging techniques such as computerized tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI).
The Veterans' Administration Lung Study Group (VALG) staging system is usually used in the clinic routine to stage SCLC. Two categories represent SCLC, limited stage (LS) and extensive stage (ES). Limited-stage small-cell lung cancer (LS-SCLC) is defined as tumour confined to one hemithorax, with or without regional lymph-node involvement, which can be safely encompassed in a tolerable radiation field, corresponding at stage I to III of TNM system. ES-SCLC is defined as disease that cannot be safely encompassed in a tolerable radiation field, corresponding to stage IV of TNM system.
The management of SCLC is complicated by aggressiveness and substantial comorbidities, and impaired performance status. According to ESMO guidelines (2021), as well as in the French guidelines from Auvergne Rhone Alpes region, the standard management design of SCLC is described and outlined in Figure 1.
Since last three decades, standard treatment in ES-SCLC is based on combination chemotherapy with a platinum agent and etoposide in first-line with or without concurrent radiation therapy. Then, the second-line of treatment is topotecan, with few results in term of response rates and survival rate.
However, the emergence of immune checkpoint inhibitors targeting the programmed cell death receptor-1 (PD-1)/PD-ligand 1 (PD-L1) pathway, having an important role in immune regulation became an alternative method in the management and care of disease. Indeed, recent studies have shown an overall survival (OS) benefit for patients with ES-SCLC treated in first line with a combination of platinum-etoposide and immune checkpoint inhibitors. Atezolizumab (Tecentriq®, Roche) and durvalumab (Imfinzi®, AstraZeneca), two anti-Programmed death-ligand 1 (PD-L1) antibodies, delivered positive phase III results, respectively through the Impower-133 and CASPIAN studies, and were granted European market authorisations.
Durvalumab (Imfinzi®, AstraZeneca), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with ES-SCLC. On March 10, 2020 French health authorities allowed durvalumab utilization in this setting through a national "early access program" (Autorisation Temporaire d'Utilisation "de cohorte" - ATUc), thus preceding the European market authorization (August 28, 2020). Since 2020 October 1st, durvalumab is used as a post ATU treatment.
Since 2020, French AURA treatment guidelines for SCLC have referenced durvalumab in combination with chemotherapy as one of the first-line treatment options for patients with ES-SCLC based on evidence from the CASPIAN phase III international randomized clinical trial, which demonstrated that adding durvalumab to chemotherapy significantly improved the median overall survival (mOS; hazard ratio: 0.73, 95% confidence interval (CI): 0.59-0.91) over chemotherapy alone.
Results from this CASPIAN study was recently updated with an assessment of 3-year overall survival. As of 2021 March, with a median follow-up 39.4 months, durvalumab plus chemotherapy continued to demonstrate a significant improvement OS versus chemotherapy alone (P = 0.0003). Authors concluded three times more patients were estimated to be alive at 3 years when treated with durvalumab plus chemotherapy versus chemotherapy, with the majority still receiving durvalumab at data cut-off, further establishing durvalumab plus chemotherapy as first-line standard of care for ES-SCLC.
To date, durvalumab has thus been available to first-line ES-SCLC patients and clinicians have the choice between atezolizumab + carboplatin-etoposide, durvalumab + carbo- or cisplatin-etoposide, and carbo- or cisplatin-etoposide alone.
Whereas the safety and efficacy of the durvalumab have been evaluated in clinical trial, data are required to further evaluate the use of durvalumab in real-life condition and in less selected population than in clinical trials, while it received EMA approval in 2020. Some studies with durvalumab were performed in real-life, but only for non-SCLC.
This observational uncontrolled prospective cohort study is conducted to complement evidence from the CASPIAN clinical trial and generate real-world evidence. There is indeed a need to describe durvalumab use in the clinical practice for the treatment of first-line ES-SCLC patients and broaden the CASPIAN results to real-life setting in France.
Therefore, the aim of this study is to describe of platinum-etoposide and durvalumab real-life utilization and effectiveness for first line ES-SCLC.
Between 2010 and 2018, the incidence rate increased of 0,3 % per year in men. In contrast, from 1990 to 2018, the incidence increased more dramatically among women, with an increase of 5% in average per year. The 5-year survival rate for all people with all types of lung cancer is 21%. The 5-year survival rate is 17% and 24% for men and women, respectively. For SCLC, due to the rapid proliferation and high growth fraction associated to early development of metastases in the disease course (most commonly to the brain, liver, or bone), the 5-year survival rate is low at 10%. Therefore, SCLC is the most lethal lung cancer subtype. Most cases of SCLC develop in patients aged 60-80 years and the estimated overall death rate is 25,000-30,000 per year in United States. More than 90% of patients with SCLC are elderly and have heavy smoking histories.
SCLC is defined histologically as "a malignant epithelial tumour consisting of small cells with scant cytoplasm, ill-defined cell borders, finely granular nuclear chromatin, and absent or inconspicuous nucleoli", assessed by imaging techniques such as computerized tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI).
The Veterans' Administration Lung Study Group (VALG) staging system is usually used in the clinic routine to stage SCLC. Two categories represent SCLC, limited stage (LS) and extensive stage (ES). Limited-stage small-cell lung cancer (LS-SCLC) is defined as tumour confined to one hemithorax, with or without regional lymph-node involvement, which can be safely encompassed in a tolerable radiation field, corresponding at stage I to III of TNM system. ES-SCLC is defined as disease that cannot be safely encompassed in a tolerable radiation field, corresponding to stage IV of TNM system.
The management of SCLC is complicated by aggressiveness and substantial comorbidities, and impaired performance status. According to ESMO guidelines (2021), as well as in the French guidelines from Auvergne Rhone Alpes region, the standard management design of SCLC is described and outlined in Figure 1.
Since last three decades, standard treatment in ES-SCLC is based on combination chemotherapy with a platinum agent and etoposide in first-line with or without concurrent radiation therapy. Then, the second-line of treatment is topotecan, with few results in term of response rates and survival rate.
However, the emergence of immune checkpoint inhibitors targeting the programmed cell death receptor-1 (PD-1)/PD-ligand 1 (PD-L1) pathway, having an important role in immune regulation became an alternative method in the management and care of disease. Indeed, recent studies have shown an overall survival (OS) benefit for patients with ES-SCLC treated in first line with a combination of platinum-etoposide and immune checkpoint inhibitors. Atezolizumab (Tecentriq®, Roche) and durvalumab (Imfinzi®, AstraZeneca), two anti-Programmed death-ligand 1 (PD-L1) antibodies, delivered positive phase III results, respectively through the Impower-133 and CASPIAN studies, and were granted European market authorisations.
Durvalumab (Imfinzi®, AstraZeneca), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with ES-SCLC. On March 10, 2020 French health authorities allowed durvalumab utilization in this setting through a national "early access program" (Autorisation Temporaire d'Utilisation "de cohorte" - ATUc), thus preceding the European market authorization (August 28, 2020). Since 2020 October 1st, durvalumab is used as a post ATU treatment.
Since 2020, French AURA treatment guidelines for SCLC have referenced durvalumab in combination with chemotherapy as one of the first-line treatment options for patients with ES-SCLC based on evidence from the CASPIAN phase III international randomized clinical trial, which demonstrated that adding durvalumab to chemotherapy significantly improved the median overall survival (mOS; hazard ratio: 0.73, 95% confidence interval (CI): 0.59-0.91) over chemotherapy alone.
Results from this CASPIAN study was recently updated with an assessment of 3-year overall survival. As of 2021 March, with a median follow-up 39.4 months, durvalumab plus chemotherapy continued to demonstrate a significant improvement OS versus chemotherapy alone (P = 0.0003). Authors concluded three times more patients were estimated to be alive at 3 years when treated with durvalumab plus chemotherapy versus chemotherapy, with the majority still receiving durvalumab at data cut-off, further establishing durvalumab plus chemotherapy as first-line standard of care for ES-SCLC.
To date, durvalumab has thus been available to first-line ES-SCLC patients and clinicians have the choice between atezolizumab + carboplatin-etoposide, durvalumab + carbo- or cisplatin-etoposide, and carbo- or cisplatin-etoposide alone.
Whereas the safety and efficacy of the durvalumab have been evaluated in clinical trial, data are required to further evaluate the use of durvalumab in real-life condition and in less selected population than in clinical trials, while it received EMA approval in 2020. Some studies with durvalumab were performed in real-life, but only for non-SCLC.
This observational uncontrolled prospective cohort study is conducted to complement evidence from the CASPIAN clinical trial and generate real-world evidence. There is indeed a need to describe durvalumab use in the clinical practice for the treatment of first-line ES-SCLC patients and broaden the CASPIAN results to real-life setting in France.
Therefore, the aim of this study is to describe of platinum-etoposide and durvalumab real-life utilization and effectiveness for first line ES-SCLC.
Conditions
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Small Cell Lung Carcinoma
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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durvalumab
Visits will be completed at W0 (durvalumab in combination with chemotherapy initiation) and at regular visits approximately every 6 weeks during the induction period (durvalumab + PE) (W6 and W12), then every two months during the maintenance period (durvalumab alone) for the first year and every three months up to the end of follow-up or the final visit at M36.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Adult patients (at least 18 years of age at time of treatment decision),
* Patients with histologically or cytologically proven SCLC and extensive disease according to the Veterans Administration Lung Study Group (VALSG) classification or TNM staging (Brierley et al, 2017) before durvalumab + platinum-etoposide treatment\*,
* Patients newly treated in first line with durvalumab + platinum-etoposide\*\*,
* Patients informed and not opposed to participating in the study.
* Patients with histologically or cytologically proven SCLC and extensive disease according to the Veterans Administration Lung Study Group (VALSG) classification or TNM staging (Brierley et al, 2017) before durvalumab + platinum-etoposide treatment\*,
* Patients newly treated in first line with durvalumab + platinum-etoposide\*\*,
* Patients informed and not opposed to participating in the study.
Exclusion Criteria
* Patients with contraindications to receiving durvalumab + platinum-etoposide,
* Patients participating in another interventional clinical trial for first line ES-SCLC.
* Patients participating in another interventional clinical trial for first line ES-SCLC.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kappa Santé
INDUSTRY
Sponsor Role
collaborator
AstraZeneca
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Research Site
Angers, , France
Site Status
Research Site
Argenteuil, , France
Site Status
Research Site
Avignon, , France
Site Status
Research Site
Avignon, , France
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Research Site
Bayonne, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Research Site
Dijon, , France
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Research Site
Epagny Metz-Tessy, , France
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Research Site
Évreux, , France
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Research Site
Gleizé, , France
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Research Site
La Roche-sur-Yon, , France
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Research Site
La Rochelle, , France
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Research Site
Le Chesnay-Rocquencourt, , France
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Research Site
Limoges, , France
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Research Site
Marseille, , France
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Research Site
Nancy, , France
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Research Site
Nîmes, , France
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Research Site
Nîmes, , France
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Research Site
Osny, , France
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Research Site
Paris, , France
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Research Site
Pau, , France
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Research Site
Rennes, , France
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Research Site
Rouen, , France
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Research Site
Saint-Etienne, , France
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Research Site
Saint-Grégoire, , France
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Research Site
Saint-Quentin, , France
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Research Site
Toulon, , France
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Research Site
Toulouse, , France
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Research Site
Toulouse, , France
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Research Site
Valenciennes, , France
Site Status
Research Site
Vannes, , France
Site Status
Research Site
Villeurbanne, , France
Site Status
Countries
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France
References
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Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
Reference Type
BACKGROUND
Oronsky B, Reid TR, Oronsky A, Carter CA. What's New in SCLC? A Review. Neoplasia. 2017 Oct;19(10):842-847. doi: 10.1016/j.neo.2017.07.007. Epub 2017 Sep 6.
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BACKGROUND
Deffossez, G. Estimations nationales de l'incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018. Volume 1 - Tumeurs solides. 2019.
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BACKGROUND
Navada S, Lai P, Schwartz AG, and Kalemkerian GP (2006). Temporal trends in small cell lung cancer: Analysis of the national Surveillance, Epidemiology, and End Results database (abstract 7082). J Clin Oncol 24(18_suppl), 7082-7082.
Reference Type
BACKGROUND
Brierley JD, Gospodarowicz MK, Wittekind C, et al, eds. TNM Classification of Malignant Tumours. 8th ed. Oxford, UK: Wiley Blackwell; 2017.
Reference Type
BACKGROUND
Avrillon V, Daniel C, Boisselier P, Le Pechoux C, Chouaid C. Nationwide Real-Life Safety and Treatment Exposure Data on Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III, Locally Advanced, Non-small Cell Lung Cancer: Analysis of Patients Enrolled in the French Early Access Program. Lung. 2022 Feb;200(1):95-105. doi: 10.1007/s00408-022-00511-8. Epub 2022 Feb 9.
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BACKGROUND
Carter BW, Glisson BS, Truong MT, Erasmus JJ. Small cell lung carcinoma: staging, imaging, and treatment considerations. Radiographics. 2014 Oct;34(6):1707-21. doi: 10.1148/rg.346140178.
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BACKGROUND
Eberhardt WE, Mitchell A, Crowley J, Kondo H, Kim YT, Turrisi A 3rd, Goldstraw P, Rami-Porta R; International Association for Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Board Members, and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for the Revision of the M Descriptors in the Forthcoming Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2015 Nov;10(11):1515-22. doi: 10.1097/JTO.0000000000000673.
Reference Type
BACKGROUND
Evans WK, Shepherd FA, Feld R, Osoba D, Dang P, Deboer G. VP-16 and cisplatin as first-line therapy for small-cell lung cancer. J Clin Oncol. 1985 Nov;3(11):1471-7. doi: 10.1200/JCO.1985.3.11.1471.
Reference Type
BACKGROUND
Goldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009.
Reference Type
BACKGROUND
Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
Reference Type
BACKGROUND
Nicholson AG, Chansky K, Crowley J, Beyruti R, Kubota K, Turrisi A, Eberhardt WE, van Meerbeeck J, Rami-Porta R; Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for the Revision of the Clinical and Pathologic Staging of Small Cell Lung Cancer in the Forthcoming Eighth Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Mar;11(3):300-11. doi: 10.1016/j.jtho.2015.10.008. Epub 2015 Dec 24.
Reference Type
BACKGROUND
Paz-Ares L, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Musso E, Havel L, Bondarenko I, Losonczy G, Conev N, Mann H, Dalvi TB, Jiang H, Goldman JW. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open. 2022 Apr;7(2):100408. doi: 10.1016/j.esmoop.2022.100408. Epub 2022 Mar 10.
Reference Type
BACKGROUND
Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.
Reference Type
BACKGROUND
Travis WD, Asamura H, Bankier AA, Beasley MB, Detterbeck F, Flieder DB, Goo JM, MacMahon H, Naidich D, Nicholson AG, Powell CA, Prokop M, Rami-Porta R, Rusch V, van Schil P, Yatabe Y; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee and Advisory Board Members. The IASLC Lung Cancer Staging Project: Proposals for Coding T Categories for Subsolid Nodules and Assessment of Tumor Size in Part-Solid Tumors in the Forthcoming Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol. 2016 Aug;11(8):1204-1223. doi: 10.1016/j.jtho.2016.03.025. Epub 2016 Apr 21.
Reference Type
BACKGROUND
Wang S, Zimmermann S, Parikh K, Mansfield AS, Adjei AA. Current Diagnosis and Management of Small-Cell Lung Cancer. Mayo Clin Proc. 2019 Aug;94(8):1599-1622. doi: 10.1016/j.mayocp.2019.01.034.
Reference Type
BACKGROUND
Wang S, Tang J, Sun T, Zheng X, Li J, Sun H, Zhou X, Zhou C, Zhang H, Cheng Z, Ma H, Sun H. Survival changes in patients with small cell lung cancer and disparities between different sexes, socioeconomic statuses and ages. Sci Rep. 2017 May 2;7(1):1339. doi: 10.1038/s41598-017-01571-0.
Reference Type
BACKGROUND
Falchero L, Tissot C, Duruisseaux M, Souquet P-J,Planchard D , et le comité de rédaction des référentiels Auvergne Rhône-Alpes en oncologie thoracique. Référentiel Cancer Bronchique à petites Cellules : actualisation 2022. ARISTOT 2022.
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BACKGROUND
APM News. L'activité de prise en charge des cancers dans les établissements Français en 2018 (Infographie). 21/11/2019.
Reference Type
BACKGROUND
Armeni P, Borsoi L, Fornaro G, Jommi C, Grossi F, Costa F. Cost-effectiveness and Net Monetary Benefit of Durvalumab Consolidation Therapy Versus No Consolidation Therapy After Chemoradiotherapy in Stage III Non-small Cell Lung Cancer in the Italian National Health Service. Clin Ther. 2020 May;42(5):830-847. doi: 10.1016/j.clinthera.2020.03.012. Epub 2020 Apr 27.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
http://oncologik.fr/referentiels/rrc/cancer-bronchique-a-petites-cellules
Dewolf, M. et al. Référentiel sur le cancer bronchique à petites cellules - Actualisation 2021. ONCOLOGIK.2021. Accessible to: http://oncologik.fr/referentiels/rrc/cancer-bronchique-a-petites-cellules (13.07.21) (2021).
http://espacecancer.sante-ra.fr/Pages/referentiels.aspx
Souquet, P.-J.,Duruisseaux, M., Mennecier, B., Tissot, C. \& Falchero, L. Référentiel sur le cancer bronchique à petites cellules - Actualisation 2020. ARISTOT.2019. Accessible to: http://espacecancer.sante-ra.fr/Pages/referentiels.aspx (05.03.21)(2020).
Other Identifiers
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D419QR00014
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)
NCT04449861
COMPLETED
PHASE3
Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer
NCT06564870
ACTIVE_NOT_RECRUITING
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
NCT04870112
TERMINATED
PHASE1
Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy
NCT05796089
ACTIVE_NOT_RECRUITING
PHASE2
A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT03693300
COMPLETED
PHASE2
A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients
NCT02879617
COMPLETED
PHASE2
Chemoradiation With Durvalumab Followed by Durvalumab Maintenance for Limited Disease Small Cell Lung Cancer
NCT03585998
UNKNOWN
PHASE2
A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Untreated Extensive Stage-Small Cell Lung Cancer Receiving Durvalumab Combined With Platinum-Etoposide in (ES-SCLC) in Brazil
NCT06008353
ACTIVE_NOT_RECRUITING
Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
NCT07309211
RECRUITING
Durvalumab as Consolidation for Patients LS-SCLC
NCT07055581
NOT_YET_RECRUITING
PHASE2
Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
NCT05572476
WITHDRAWN
PHASE2
Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer
NCT03030131
TERMINATED
PHASE2
A Study of Durvalumab Plus Tremelimumab With Chemotherapy in Untreated ES-SCLC
NCT03963414
TERMINATED
PHASE1
Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.
NCT06992609
RECRUITING
PHASE3
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
NCT03995875
COMPLETED
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients
NCT03706690
ACTIVE_NOT_RECRUITING
PHASE3
Immunotherapy as Second-line in Patient With Small Cell Lung Cancer
NCT03059667
COMPLETED
PHASE2
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
NCT04712903
COMPLETED
PHASE3
Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)
NCT03319316
WITHDRAWN
PHASE2
Quick Start Durvalumab Following Chemoradiation for Stage III Nonsmall Cell Lung Cancer
NCT05696782
RECRUITING
PHASE2
Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects
NCT04361825
COMPLETED
PHASE2
1st Line Durvalumab in PS 2 NSCLC Patients
NCT03620669
ACTIVE_NOT_RECRUITING
PHASE2
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
NCT03898791
COMPLETED
PHASE1
A Real-world Study of Durvalumab for Lung Cancer in China
NCT04672759
UNKNOWN