Informations générales (source: ClinicalTrials.gov)
DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy
Interventional
Phase 1
Boehringer Ingelheim (Voir sur ClinicalTrials)
janvier 2024
avril 2026
20 septembre 2024
This study is open to adults with extensive stage small cell lung cancer. The study is in
people with advanced cancer that had previously received platinum-based chemotherapy and
are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can
tolerate when taken together with a single agent chemotherapy. BI 764532 is an
antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and
can tolerate it. 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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 19/06/2024 13:50:27 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOP Civil - 67091 - Strasbourg - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. 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).
2. Signed and dated written informed consent in accordance with International
Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation
prior to admission to the trial.
3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients
with tumours with mixed histology are eligible only if SCLC component is predominant
and represent at least 50% of the overall tumour tissue.
4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred
following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1)
or programmed cell death ligand 1 (PD-L1) as applicable.
5. Patients must be eligible for single agent chemotherapy treatment (used in the
trial) according to label.
6. Availability of archival tumour tissue sample.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further
inclusion criteria apply.
1. 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).
2. Signed and dated written informed consent in accordance with International
Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation
prior to admission to the trial.
3. Histologically or cytologically confirmed small cell lung cancer (SCLC). Patients
with tumours with mixed histology are eligible only if SCLC component is predominant
and represent at least 50% of the overall tumour tissue.
4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred
following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1)
or programmed cell death ligand 1 (PD-L1) as applicable.
5. Patients must be eligible for single agent chemotherapy treatment (used in the
trial) according to label.
6. Availability of archival tumour tissue sample.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Further
inclusion criteria apply.
1. Previous treatment in this trial.
2. Current enrolment in another investigational device or drug trial, or <30 days since
ending another investigational device or drug trial(s).
3. Untreated or symptomatic brain metastases. Participants with treated, stable brain
metastases are eligible provided they meet the following criteria:
- Radiotherapy or major surgery for brain metastases was completed at least 2
weeks (for radiotherapy) or 4 weeks (for major brain metastases surgery) prior
to the first administration of BI 764532.
- Patient is off steroids for at least 7 days (physiologic doses of steroids are
permitted), and the patient is off anti-epileptic drugs for at least 7 days or
on stable doses of anti-epileptic drugs for malignant central nervous system
(CNS) disease.
4. Presence of leptomeningeal carcinomatosis.
5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like
ligand 3 (DLL3).
6. 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).
7. 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.
8. Previous or concomitant malignancies other than the one treated in this trial within
the last 2 years except
1. effectively treated non-melanoma skin cancers
2. effectively treated carcinoma in situ of the cervix
3. effectively treated ductal carcinoma in situ
4. other effectively treated malignancy that is considered cured by local
treatment Further exclusion criteria apply.