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

NCT05683977 | Active Not Recruiting FDA Drug

• 1 other identifier: D419QR00014
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 34

Brief 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.

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Real-world Overall Survival (rwOS)

  rwOS rate at 1, 2 and 3 years (rwOS1y, rwOS2y, rwOS3y)

• Real world Progression Free Survival (rwPFS)

  rwPFS rate at 6, 12, 18, 24 and 36 months (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m) up to 36 months.

• Patient individual best response

  From the start of treatment until disease progression (up to 36 months)..

• Overall response rate (ORR)

  From the start of treatment until disease progression (up to 36 months).

• Disease control rate (DCR)

  At the end of follow-up (up to 36 months)

Other Outcomes (18)

• Describe the nature and explore the impact of different sequential therapeutical strategies on patient outcomes.

  At the end of follow-up (up to 36 months)

• Explore disease characteristics, that may influence the progression of cancer and/or response to durvalumab + platinum etoposide treatment

  At the end of follow-up (up to 36 months).

• Time between chemotherapy and durvalumab initiation:

  Between chemotherapy and durvalumab initiation (up to 1 year)

Interventions

durvalumab DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Total population: all patients enrolled * Safety analysis set: the safety population will be defined as all patients who receive at least one infusion of durvalumab. * Full analysis set: the full analysis set will comprise all patients who receive at least one infusion of durvalumab and meet eligibility criteria. * Follow up analysis set: it will comprise all patients of the full analysis set who have at least one follow up visit completed.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead
• Kappa Santé: collaborator

Study Sites (34)

Research Site

Angers, 49933, France

Location

Research Site

Argenteuil, 95107, France

Location

Research Site

Avignon, 84000, France

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Avignon, 84918, France

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Bayonne, 64100, France

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Bordeaux, 33077, France

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Clermont-Ferrand, 63000, France

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Créteil, 94000, France

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Dijon, 21000, France

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Epagny Metz-Tessy, 74370, France

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Évreux, 27015, France

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Gleizé, 69400, France

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La Roche-sur-Yon, 85925, France

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La Rochelle, 17000, France

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Le Chesnay-Rocquencourt, 78150, France

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Limoges, 87000, France

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Marseille, 13008, France

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Nancy, 54100, France

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Nîmes, 30000, France

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Nîmes, 30900, France

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Osny, 95520, France

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Paris, 75005, France

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Pau, 64000, France

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Rennes, France

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Rouen, 76000, France

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Saint-Etienne, 42100, France

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Saint-Grégoire, 35760, France

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Saint-Quentin, 2321, France

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Toulon, 83000, France

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Toulouse, 31076, France

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Toulouse, 31400, France

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Valenciennes, 59300, France

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Vannes, 56017, France

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Villeurbanne, 69100, France

Location

Related Publications (20)

• 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.

  PMID: 35141799 BACKGROUND

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  PMID: 25310425 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.

  PMID: 26536193 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.

  PMID: 2997406 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.

  PMID: 26762738 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.

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• 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.

  PMID: 26723244 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.

  PMID: 35279527 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.

  PMID: 31590988 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.

  PMID: 27107787 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.

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• 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.

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• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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• 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.

  PMID: 32354495 RESULT

Related Links

• 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).
• ASCO 2021

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: January 13, 2023
• Study Start: November 14, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (34)