Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05223647

Abgebrochen

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

Interventionsstudie

Phase 3

Linköping University Hospital

Sponsor: Norwegian University of Science and Technology

Zuletzt aktualisiert: 6. Juni 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Eingriff, Andere Medikamente

Erforderliche Mutationen

Keine

Studie gestartet

11. Januar 2022

Zuletzt vom Sponsor aktualisiert

6. Juni 2025

Voraussichtlicher Abschluss

1. Januar 2026

Studienkontakt

Name:Bjørn H Grønberg, MD, PhD

E-Mail:bjorn.h.gronberg@ntnu.no

Telefon:47297878

Name:Trude C Frøseth, MSc

E-Mail:triplex@stolav.no

Telefon:N/A

Eignung

Einschlusskriterien

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 30 Gy/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 treated and stable on steroids and/or anticonvulsants prior to the start of treatment

Ausschlusskriterien

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

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer302

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course.

Interventionen:

Thoracic radiotherapy
Chemo-immunotherapy

Ergebnismessungen

Primäre Ergebnismessungen

Change in 1-year overall survival14 months after last patient entry

The Cox proportional hazards method will be used to compare survival between the treatment groups.

Sekundäre Ergebnismessungen

Change in 2-, 3-, 4- and 5-year survival rate2, 3, 4 and 5 years after last patient entry

The Cox proportional hazards method will be used to compare survival between the treatment groups.

Frequency and severity of adverse eventsThrough study completion, an average of 1 year after last patient entry

Adverse events will be compared between the treatment arms using the Pearson's Chi-square and Fisher's exact test.

Change in progression free survival (PFS)Through study completion, an average of 1 year after last patient entry

PFS will be estimated using the Kaplan-Meier method and compared using the log-rank test. A Cox-model adjusting for baseline characteristics will be used for multivariable analyses.

Change in overall response ratesThrough study completion, an average of 1 year after last patient entry

Response rates are compared using Pearson's Chi-square test.

Change in response rates in non-irradiated lesionsThrough study completion, an average of 1 year after last patient entry

Response rates are compared using Pearson's Chi-square test.

Local control rates in the thoraxThrough study completion, an average of 1 year after last patient entry

Local control rates are compared using Pearson's Chi-square test.

Health-related quality of life (HRQoL)Through study completion, an average of 1 year after last patient entry

All HRQoL scores will be transformed to a scale of 0-100 according to the EORTC QLQ scoring manual. Mean scores will be compared at each assessment timepoint, and a difference of 10 points is considered clinically relevant.

Change in cognitive function from baseline to end of treatmentThrough study completion, an average of 2 years after last patient entry

Cognitive function will be compared between patients who receive PCI and those who do not, using the MoCA-test. Scores will be compared using the Mann-Whitney test.

Frequency and timing of brain metastasesThrough study completion, an average of 2 years after last patient entry

Changes in brain metastases are compared using Pearson's Chi-square test.

Associations between outcomes of study treatment and biomarkers in tissue, blood and stoolThrough study completion, an average of 2 years after last patient entry

A detailed plan for analyses will be defined when sufficient material for translational research has been collected.

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Studienzentren

Diese Studie hat 20 Studienzentren

Linköping University Hospital

Linköping, SE

Name:Anders Vikström

Rekrutierend

Linköping, SE

Linköping University Hospital

Rekrutierend

Bergen, NO

Haukeland Universitetssykehus

Rekrutierend

Levanger, NO

Sykehuset Levanger

Rekrutierend

Tromsø, NO

University Hospital of North Norway, Pulmonology Department

Rekrutierend

Trondheim, NO

Cancer Clinic at St. Olavs Hospital

Rekrutierend

Göteborg, SE

Sahlgrenska Sjukehuset

Rekrutierend

Stockholm, SE

Karolinska University Hospital

Rekrutierend

Ålesund, NO

Ålesund Hospital

Rekrutierend

Rotterdam, NL

Erasmus MC

Rekrutierend

Stavanger, NO

Stavanger University Hospital

Rekrutierend

Drammen, NO

Drammen sykehus - Vestre Viken

Rekrutierend

Oslo, NO

Akershus Universitetssykehus AHUS

Rekrutierend

Oslo, NO

Oslo University Hospital Ullevål

Rekrutierend

Tallinn, EE

North Estonia Medical Centre

Rekrutierend

Haugesund, NO

Haugesund hospital

Rekrutierend

Gävle, SE

Gävle hospital

Rekrutierend

Gjøvik, NO

Innlandet hospital Gjøvik

Rekrutierend

Reykjavík, IS

Landspitali University Hospital

Rekrutierend

Bodø, NO

Nordlandssykehuset HF

Rekrutierend

Skåne, SE

Lund University Hospital

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