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JOURNAL ONKOLOGIE – STUDIE
DAREONᵀᴹ-8

DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT06077500

Studienbeginn:
Januar 2024

Letztes Update:
01.05.2024

Wirkstoff:
BI 764532, Carboplatin, Etoposide, Atezolizumab, Durvalumab, Cisplatin

Indikation (Clinical Trials):
Carcinoma, Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Studienlocations
(3 von 14)

Universitätsklinikum Gießen und Marburg GmbH
35392 Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
60-693 Poznan
PolandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 008001218830
E-Mail: polska@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This study is open to adults with extensive stage small cell lung cancer. The study is in

people with advanced cancer that are eligible for standard of care including chemotherapy and

anti-PD-L1 (Programmed Cell Death Ligand 1) immunotherapy.

The purpose of this study is to find out the highest dose of BI 764532 that people can

tolerate when taken together with standard of care. BI 764532 is an antibody-like molecule

that may help the immune system fight cancer. Participants get BI 764532 and different

standard treatments as infusions into a vein.

If there is benefit for the participants and if they can tolerate it, the treatment is given

for the entire duration of the study. During this time, participants visit the study site

regularly. The visits also depend on the response to the treatment. At the study visits, the

doctors check the health of the participants, take necessary laboratory tests, and note any

health problems that could have been caused by the study treatment.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Male or female participants ≥18 years old and at least at the legal age of consent in

countries where it is greater than 18 years at the time of signature of the informed

consent form (ICF)

- Signed and dated written informed consent in accordance with International Council for

Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to

admission to the trial

- Histologically or cytologically confirmed extensive-stage small cell lung carcinoma

(ES-SCLC)

- Availability of archival tumour tissue

- Patients must be eligible for platinum+etoposide+anti-Programmed Cell Death Ligand 1

(PD-L1) regimen as first line standard of care (SoC) treatment:

- In Part A, patients must be eligible to receive carboplatin + etoposide +

atezolizumab

- In Part B, patients must be eligible to receive etoposide, carboplatin or

cisplatin, and atezolizumab or durvalumab

- No prior systemic treatment for ES-SCLC

- Prior systematic anti-cancer treatment for limited-stage small cell lung cancer (SCLC)

must have been complete at least 6 months prior to the diagnosis of ES-SCLC

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion

criteria apply.

Exclusion Criteria:

- Previous treatment in this trial

- Treatment with a systemic anti-cancer therapy or investigational drug within 28 days

or 5 half-lives (whichever is longer) of the first administration of trial medication

- Presence of leptomeningeal carcinomatosis

- Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers and cell

therapies

- Patients who have been treated with extensive field radiotherapy including whole brain

irradiation within 2 weeks prior to first administration of BI 764532

- Persistent toxicity from previous treatments that has not resolved to ≤ Common

Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia,

asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by

replacement therapy)

- Major surgery (major according to the investigator's assessment) within 28 days prior

to first administration of BI 764532 or planned during treatment period, e.g. hip

replacement

- Any documented active or suspected malignancy or history of malignancy within 5 years

prior to Screening (other than the target indication), except for appropriately

treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix

Further exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (Time Frame - up to 6 weeks)

2. Part B - Dose expansion: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period (Time Frame - up to 23 months)

Secondary outcome:

1. Part A - Dose escalation: Occurrence of dose limiting toxicities (DLTs) during the on-treatment period (Time Frame - up to 23 months)

2. Part A - Dose escalation: Occurrence of adverse events (AEs) during the on-treatment period (Time Frame - up to 23 months)

3. Part B - Dose expansion: Objective response (OR) (Time Frame - up to 23 months):
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent

4. Part B - Dose expansion: Duration of response (DoR) (Time Frame - up to 23 months):
DoR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response

Studien-Arme

  • Experimental: Part A - Dose escalation: BI 764532 very low dose + carboplatin + etoposide + atezolizumab
  • Experimental: Part A - Dose escalation: BI 764532 low dose + carboplatin + etoposide + atezolizumab
  • Experimental: Part A - Dose escalation: BI 764532 medium dose + carboplatin + etoposide + atezolizumab
  • Experimental: Part A - Dose escalation: BI 764532 high dose + carboplatin + etoposide + atezolizumab
  • Experimental: Part B - Dose expansion: BI 764532 + carboplatin + etoposide + atezolizumab
  • Experimental: Part B - Dose expansion: BI 764532 + carboplatin + etoposide + durvalumab
  • Experimental: Part B - Dose expansion: BI 764532 + cisplatin + etoposide + durvalumab

Geprüfte Regime

  • BI 764532:
    BI 764532
  • Carboplatin:
    Carboplatin
  • Etoposide:
    Etoposide
  • Atezolizumab:
    Atezolizumab
  • Durvalumab:
    Durvalumab
  • Cisplatin:
    Cisplatin

Quelle: ClinicalTrials.gov


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