This study has been transitioned to CTIS with ID 2024-511021-58-00 check the CTIS register for the current data. Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events -…
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract neoplasms
Synonym
Health condition
kleincellig longkanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dose-limiting toxicities (DLTs), treatment-emergent and treatment-related
adverse events, changes in vital signs, electrocardiograms (ECGs), and clinical
laboratory tests.
Secondary outcome
- Progression free survival, will be based on modified Response Evaluation
Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Objective response, based on modified RECIST v1.1
- Duration Of Response, and Disease control, as per modified RECIST v1.1.
- Overall survival (OS) as per modified RECIST v1.1
- Serum concentrations of tarlatamab.
Background summary
Small cell lung cancer is accounting for 10% to 15% cases of lung cancer and
strongly associated with smoking. It is characterized by an aggressive course;
fast time doubling, high fraction of growth and emergence distant metastases
within a short time from diagnosis. While 30% of patients present with disease
limited to 1 hemithorax - half breast (limited disease [LD]), the majority have
extensive disease [ED]. Small cell lung cancer is exquisitely sensitive to
first-line chemotherapy and to radiation but is subsequently resistant to
second-line and subsequent therapies after disease recurrence. Patients with
ED develop drug resistance and die as a result of disease at a median time of
10 to 12 months from diagnosis.
Study objective
This study has been transitioned to CTIS with ID 2024-511021-58-00 check the CTIS register for the current data.
Primary Objective:
- Number of participants with dose limiting toxicity
- Number of participants with treatment-related adverse events
- Number of participants with treatment-emergent adverse events
- Number of participants with changes in vital signs
- Number of participants with changes in electrocardiogram
- Number of participants with changes in clinical laboratory tests
Secondary Objective:
- 6-month progression free survival per modified Response Evaluation Criteria
in Solid Tumors version 1.1
- Objective response per modified Response Evaluation Criteria in Solid Tumors
version 1.1
- Duration of response per modified Response Evaluation Criteria in Solid
Tumors version 1.1
- Disease control per modified Response Evaluation Criteria in Solid Tumors
version 1.1
- Overall survival per modified Response Evaluation Criteria in Solid Tumors
version 1.1
- Characterization of pharmacokinetics of Tarlatamab in combination with
anti-PDL1 with or without chemotherapy
Study design
This is a phase 1b study evaluating the safety, tolerability, and preliminary
efficacy of first-line tarlatamab (study drug under investigation) in
combination with standard of care chemo-immunotherapy in subjects with
Extensive Stage Small Cell Lung Cancer. This study is open label, subject and
study staff will know the treatment received on study.
Intervention
Tarlatamab will be evaluated
- in combination with chemo-immunotherapy followed by maintenance cycles of
tarlatamab plus PD-L1 inhibitor, and
- as maintenance only in combination with tarlatamab plus PD-L1 inhibitor
following standard of care chemo-immunotherapy.
Both atezolizumab and durvalumab separately will be evaluated in combination
with tarlatamab.
Study burden and risks
There is an unmet need to provide further therapeutic options for patients
diagnosed with extensive stage small cell lung cancer. Based on ongoing
experince with tarlatamab in a phase 1, first-in-human, setting, safety data
has been generated to proceed in combination with standard of care.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Age
Inclusion criteria
• Participant has provided informed consent/assent prior to initiation of any
study specific activities/procedures
• Age greater than or equal to 18 years old at the same time of signing the
informed consent
• Participants with histologically or cytologically confirmed Extended Stage
Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC
other than protocol defined standard of care first line therapy prior to
enrollment. Subjects with prior treatment for limited stage SCLC (LS-SCLC) are
permitted.
• Eastern Cooperative Oncology Group (ECOG) 0 to 1
• Participants with treated asymptomatic brain metastases are eligible provided
they meet defined criteria
• Adequate organ function as defined in protocol
Please refer to section 5.1 of the protocol for the full list of inclusion
criteria and any changes in these following protocol amendment 3.
Exclusion criteria
• History of other malignancy within the past 2 years with exceptions
• Major surgery within 28 days of study day 1
• Untreated or symptomatic brain metastases and leptomeningeal disease
Please refer to section 5.2 of the protocol for the full list of exclusion
criteria and any changes in these following protocol amendment 3.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511021-58-00 |
| EudraCT | EUCTR2021-005462-17-NL |
| ClinicalTrials.gov | NCT05361395 |
| CCMO | NL79883.056.22 |