A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.

Small Cell Lung Carcinoma Clinical Trial

— ARSENAL  

Official title:

EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer. Prospective Cohort of Extensive Stage Small Cell Lung Cancer Patients Treated With Durvalumab Associated With Platinum-etoposide Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683977
• Other study ID #: D419QR00014
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: April 16, 2027

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 16, 2027
• Est. primary completion date: April 16, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Exclusion Criteria:

• Patients with contraindications to receiving durvalumab + platinum-etoposide,
• Patients participating in another interventional clinical trial for first line ES-SCLC.

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	Research Site	Angers
France	Research Site	Argenteuil
France	Research Site	Avignon
France	Research Site	Avignon
France	Research Site	Bayonne
France	Research Site	Bordeaux Cedex
France	Research Site	Clermont-Ferrand
France	Research Site	Créteil
France	Research Site	Dijon
France	Research Site	Epagny Metz-Tessy
France	Research Site	Évreux
France	Research Site	Gleize
France	Research Site	La Roche sur Yon
France	Research Site	La Rochelle
France	Research Site	Le Chesnay-Rocquencourt
France	Research Site	Limoges
France	Research Site	Marseille
France	Research Site	Nancy
France	Research Site	Nimes
France	Research Site	Nîmes
France	Research Site	Osny
France	Research Site	Paris
France	Research Site	Pau
France	Research Site	Rennes
France	Research Site	Rouen
France	Research Site	Saint Gregoire
France	Research Site	Saint-Etienne
France	Research Site	Saint-Quentin
France	Research Site	Toulon
France	Research Site	Toulouse
France	Research Site	Toulouse
France	Research Site	Valenciennes
France	Research Site	Vannes
France	Research Site	Villeurbanne

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Kappa Santé

Country where clinical trial is conducted

France, 

References & Publications (20)

APM News. L'activité de prise en charge des cancers dans les établissements Français en 2018 (Infographie). 21/11/2019.

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 Natio — View Citation

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. — View Citation

Brierley JD, Gospodarowicz MK, Wittekind C, et al, eds. TNM Classification of Malignant Tumours. 8th ed. Oxford, UK: Wiley Blackwell; 2017.

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. — View Citation

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.

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. — View Citation

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. — View Citation

Falchero L, Tissot C, Duruisseaux M, Souquet P-J,Planchard D , et le comite´ de rédaction des référentiels Auvergne Rho^ne-Alpes en oncologie thoracique. Référentiel Cancer Bronchique a` petites Cellules : actualisation 2022. ARISTOT 2022.

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe the nature and explore the impact of different sequential therapeutical strategies on patient outcomes.	The impact of different sequential therapeutical strategies (including local and systemic treatments) on patient outcomes will be described in terms of: - Treatment pathways description (sequences description, duration of sequences),	At the end of follow-up (up to 36 months)
Other	Explore disease characteristics, that may influence the progression of cancer and/or response to durvalumab + platinum etoposide treatment	The association between clinical and biomolecular disease characteristics and cancer progression or response to treatment will be investigated.	At the end of follow-up (up to 36 months).
Other	Time between chemotherapy and durvalumab initiation:	Time between chemotherapy and durvalumab initiation is defined as the time from date of first infusion of platinum etoposide to the date of first infusion of durvalumab.	Between chemotherapy and durvalumab initiation (up to 1 year)
Other	Dosing regimen and scheme	Proportion of patients receiving durvalumab-etoposide-cisplatin,; . Proportion of patients receiving durvalumab-etoposide-carboplatin,; Proportion of patients receiving the combination durvalumab plus PE at first infusion (first cycle),; Proportion of patients receiving PE at first infusion and durvalumab at a later cycle (if later, initiation cycle),	At the end of follow-up (up to 36 months)
Other	Chemotherapy cycles description	Proportion of patients treated with 4 cycles/ 6 cycles before maintenance period,; Proportion of patients with doses modifications during treatment, description of the changes,; Proportion of patients with delayed cycles and reason for delay.	At the end of follow-up (up to 36 months)
Other	Number of durvalumab cycles	Number of cycles with durvalumab in combination with PE (induction period),; Number of cycles with durvalumab in monotherapy (maintenance period),	At the end of follow-up -up to 36 months)
Other	Duration of treatment	Mean and median duration of first line treatment from the date of first infusion of durvalumab and /or PE to the date of last infusion of durvalumab.	At the end of follow-up (up to 36 months).
Other	Time to first subsequent therapy (TFST)	TFST is defined as the time from the index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of subsequent therapy or the date of death. For patients still receiving durvalumab at the end of follow-up, TFST will be right-censored at the last recorded day of ongoing durvalumab treatment.	At the end of the follow-up (up to 36 months).
Other	Time to second subsequent therapy (TSST)	TSST is defined as the time from the index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of second subsequent therapy or date of death. For patients still receiving durvalumab at the end of follow-up, TSST will be right-censored at the last recorded day of ongoing durvalumab treatment.	At the end of follow-up (up to 36 months).
Other	Local and supportive treatments	Proportion of patients with mediastinal irradiation while on durvalumab treatment,; Proportion of patients with prophylactic cranial irradiation while on durvalumab treatment,; Proportion of patients with other irradiation while on durvalumab treatment,; Proportion of patients with surgery while on durvalumab treatment,; Proportion of patients with GCS-F while on durvalumab treatment,; Proportion of patients with EPO while on durvalumab treatment,; Proportion of patients with phosphonate while on durvalumab treatment,	At the end of follow-up (up to 36 months).
Other	Describe the nature and explore the impact of different sequential therapeutical strategies on patient outcomes.	- Pattern of tumor progression, rwPFS2, TFST, TSST).	At the end of follow-up (up to 36 months)
Other	Describe the nature and explore the impact of different sequential therapeutical strategies on patient outcomes.	- Treatment effectiveness (ORR, DCR, mrwOS, mrwPFS, mrwPFS2, TFST, TSST).	At the end of follow-up (up to 36 months)
Other	Dosing regimen and scheme	Description of dosage for durvalumab plus PE at initiation; Description of reasons for platinum salt choice (better tolerance, better efficacy, hospital protocol, patient status, age, other),	At the end of follow-up (up to 36 months)
Other	Number of chemotherapy cycles	Number of cycles with platinum-etoposide,	At the end of follow-up (up to 36 months)
Other	Chemotherapy cycles delays	- Time between each cycle,	At the end of follow-up (up to 36 months)
Other	Durvalumab cycles delays	- Time between each cycle,	At the end of follow-up (up to 36 months)
Other	Description of durvalumab cycles	- Proportion of patients with delayed cycles and reason for delay.	At the end of follow-up (up to 36 months)
Other	Local and supportive treatments timeline	Time between the end of induction period and the first local treatment (mediastinal irradiation or prophylactic cranial irradiation).	At the end of follow-up (up to 36 months)
Primary	The time to first line treatment discontinuation (TTD).	For patients who start durvalumab at a later cycle than first cycle PE, the index date will be the first infusion of PE.; If the treatment is stopped during the first phase of 4 to 6 cycles (induction) with a new re- start of durvalumab and PE, the treatment will be considered as temporary stop. If the treatment is stopped during the durvalumab maintenance with a re-start of durvalumab in monotherapy, the treatment will be also considered as temporary stop.; Durvalumab will be considered definitely discontinued when the maintenance phase with durvalumab in monotherapy is stopped and results in a new administration of PE (+/-durvalumab) (subsequent treatment line).; For patients still receiving durvalumab at the end of follow-up or when they are lost to follow-up, TTD will be right-censored at the last recorded day of ongoing durvalumab treatment.	TTD is defined as the time from the index date to the date of last durvalumab infusion (+3 weeks during induction period and +4 weeks during maintenance period) or date of death (up to 36 months)).
Secondary	Real-world Overall Survival (rwOS)	rwOS is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to date of death due to any cause. rwOS will be censored on the last date patient is known to be alive.; rwOS rate at 1, 2 and 3 years (rwOS1y, rwOS2y, rwOS3y) and median real-world overall survival (mrwOS) will be assessed.	rwOS rate at 1, 2 and 3 years (rwOS1y, rwOS2y, rwOS3y)
Secondary	Real world Progression Free Survival (rwPFS)	rwPFS is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of disease progression as assessed by physicians or the date of death, whichever occurs first. rwPFS will be censored on the date of last follow-up.; The rwPFS date will be based on the investigator's judgement. The real-world progression may be based on radiological evaluation or clinical judgement, or other measure to compensate absence of RECIST criteria.; rwPFS rate at 6, 12, 18, 24 and 36 months (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m) and median rwPFS (mrwPFS) will be assessed.	rwPFS rate at 6, 12, 18, 24 and 36 months (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m) up to 36 months.
Secondary	Patient individual best response	The tumour response will be assessed by investigator as Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD). The patient individual best response is defined as the best response recorded from the start of treatment until disease progression.; The proportion of patients with a CR as best response, with a PR as best response, with SD as best response and with PD as best response will be assessed.	From the start of treatment until disease progression (up to 36 months)..
Secondary	Overall response rate (ORR)	ORR is defined as proportion of patients with at least one complete response (CR) or partial response (PR) at least one visit (Paz Ares et al, 2019).	From the start of treatment until disease progression (up to 36 months).
Secondary	Disease control rate (DCR)	DCR is defined as the proportion of patients with at least one complete response (CR), partial response (PR) or stable disease.	At the end of follow-up (up to 36 months)
Secondary	Time to second real-world progression (rwPFS2)	rwPFS2 is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the second record of disease progression determined by physicians' assessment, or death. rwPFS2 will be right-censored at the date of last follow-up.	rwPFS2 (up to 36 months)
Secondary	Sociodemographics characteristics at durvalumab + platinum-etoposide initiation	Age	At baseline
Secondary	Describe patient history prior to durvalumab initiation	Proportion of patients with previous history of cancer, Proportion of patients with history of paraneoplastic syndromes, Proportion of patients with history of auto-immune disease (including past, stabilized or active disease, disease duration), Proportion of patient treated with antibiotics, corticosteroids or other immunosuppressive therapy in the last 4 weeks before treatment initiation.; Treatment history at durvalumab + platinum-etoposide initiation will be described in terms of: Proportion of patients with previous SCLC anti-cancer therapy (for limited and extensive stage),; Proportion of patients with previous auto-immune disease associated treatment, Proportion of patients with previous non cancer therapies of interest (immunosuppressive therapy, nephrotoxic and anti-inflammatory drugs, antibiotherapy, corticosteroid therapy, supportive treatments).	Before durvalumab initiation
Secondary	Describe the safety profile of durvalumab + chemotherapy (PE) (treatment-related AE).	Safety profile of durvalumab + platinum-etoposide will be described in terms of: Incidence rate of grade =3 durvalumab -related according to Common Terminology Criteria for Adverse Events (CTCAE),; Incidence rate of durvalumab -related immune-related AEs (imAE),; Incidence rate of SAEs, AESIs, AEs resulting in treatment modification,; Incidence rate of AEs resulting in treatment discontinuation,	At the end of follow-up (up to 36 months).
Secondary	Sociodemographics characteristics at durvalumab + platinum-etoposide initiation	Gender	At baseline
Secondary	Sociodemographics characteristics at durvalumab + platinum-etoposide initiation	BMI	At baseline
Secondary	Sociodemographics characteristics at durvalumab + platinum-etoposide initiation	Smoking status	At baseline
Secondary	Clinical characteristics at durvalumab + platinum-etoposide initiation	Duration between initial SCLC diagnosis and ES-SCLC for patients with first diagnosis at limited stage,; Duration between initial ES-SCLC diagnosis and treatment initiation,	At baseline
Secondary	Clinical characteristics at durvalumab + platinum-etoposide initiation	- Disease stage at tumour diagnosis (limited or extensive stage; number of metastatic sites) and at baseline,	At baseline
Secondary	Clinical characteristics at durvalumab + platinum-etoposide initiation	- Actual number and localization of metastases at baseline including brain metastases (symptomatic or asymptomatic, treated or not), bone metastases (extension), and liver metastases,	At baseline
Secondary	Clinical characteristics at durvalumab + platinum-etoposide initiation	- Performance status at baseline (before durvalumab initiation),	At baseline
Secondary	Clinical characteristics at durvalumab + platinum-etoposide initiation	Comorbidities.	At baseline
Secondary	Describe patient history prior to durvalumab initiation	Time from discontinuation of the last treatment received for limited stage to start of first treatment for extensive stage	Before durvalumab discontinuation
Secondary	Safety profile of durvalumab + chemotherapy (PE) (treatment-related AE).	- Description of concomitant treatments including nephrotoxic and steroids-immunosuppressive drugs used to manage durvalumab related adverse events.	At the end of follow-up (up to 36 months).

External Links

•   ASCO 2021
•   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).
•   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).