Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer

Last updated: January 2, 2024
Sponsor: Norwegian University of Science and Technology
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Chemo-immunotherapy

Thoracic radiotherapy

Clinical Study ID

NCT05223647
EC#230766
2020203
  • Ages > 18
  • All Genders

Study Summary

Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years at time of study entry
  2. ECOG performance status of 0 or 1
  3. Body weight >30 kg
  4. Adequate bone marrow, liver and kidney function
  5. Life expectancy of at least 3 months
  6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30Gy/10 fractions
  7. Histologically or cytologically confirmed SCLC
  8. Stage III-IV disease (TNM v8)
  9. FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
  10. Patients with brain metastases are eligible provided they are asymptomatic or treatedand stable on steroids and/or anticonvulsants prior to the start of treatment

Exclusion

Exclusion Criteria:

  1. Previous chemo-, immuno- or radiotherapy for SCLC
  2. Major surgical procedure last 28 days
  3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency,hepatitis or HIV
  4. Uncontrolled intercurrent illness
  5. Other active malignancy
  6. Leptomeningeal carcinomatosis
  7. Immunosuppressive medication
  8. Pregnant or breastfeeding women

Study Design

Total Participants: 302
Treatment Group(s): 2
Primary Treatment: Chemo-immunotherapy
Phase: 3
Study Start date:
January 11, 2022
Estimated Completion Date:
October 31, 2029

Study Description

Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypothesized that there is a synergistic effect of combining ICI with radiotherapy. In this randomized phase III study, the main aim is to investigate whether concurrent thoracic radiotherapy of 30 Gy/10 fractions improves survival in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers.

Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.

Connect with a study center

  • Rigshospitalet København

    København,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • North Estonia Medical Centre

    Tallinn,
    Estonia

    Active - Recruiting

  • Landspitali University Hospital

    Reykjavík,
    Iceland

    Active - Recruiting

  • National Cancer Institute

    Vilnius,
    Lithuania

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Haukeland Universitetssykehus

    Bergen,
    Norway

    Active - Recruiting

  • Nordlandssykehuset HF

    Bodø,
    Norway

    Active - Recruiting

  • Drammen sykehus - Vestre Viken

    Drammen,
    Norway

    Active - Recruiting

  • Innlandet hospital Gjøvik

    Gjøvik,
    Norway

    Active - Recruiting

  • Haugesund hospital

    Haugesund,
    Norway

    Active - Recruiting

  • Sykehuset Levanger

    Levanger,
    Norway

    Active - Recruiting

  • Akershus Universitetssykehus AHUS

    Oslo,
    Norway

    Active - Recruiting

  • Oslo University Hospital Ullevål

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • University Hospital of North Norway, Pulmonology Department

    Tromsø,
    Norway

    Active - Recruiting

  • Cancer Clinic at St. Olavs Hospital

    Trondheim,
    Norway

    Active - Recruiting

  • Ålesund Hospital

    Ålesund,
    Norway

    Active - Recruiting

  • Gävle hospital

    Gävle,
    Sweden

    Active - Recruiting

  • Sahlgrenska Sjukehuset

    Göteborg,
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linköping,
    Sweden

    Active - Recruiting

  • Lund University Hospital

    Skåne,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

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