A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301)
- Conditions
- kleincellig longkankerlung cancerSmall Cell Lung Cancer10029107
- Registration Number
- NL-OMON54228
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
o Male and female subjects (>= 18 years of age) at the time of signing the
inform consent
o Histologically or cytologically confirmed relapsed/refractory SCLC
o Subject who progressed or recurred following 1 platinum-based regimen and at
least 1 other prior line of therapy
(Note: [1] re-treatment with a platinum-based regimen is considered a second
line of therapy; [2] platinum-based regimen followed by checkpoint
inhibitor/anti-programmed death ligand 1 [PD-L1] as maintenance therapy is
considered 1 line of therapy; [3] in countries where standard of care first
line systemic treatment includes platinum
containing chemotherapy in combination with PD-L1 inhibitor, it is required
that subjects have failed PD-L1 inhibitor as part of their first line systemic
treatment or are ineligible to receive PDL1 inhibitor therapy.
For more information, see section 5.1 of the protocol.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Has evidence of interstitial lung disease or active, non-infectious
pneumonitis.
- Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe,
life-threatening immune-mediated adverse events or infusion-related reactions
including those that lead to permanent discontinuation while on treatment with
immuno-oncology agents.
- Unresolved toxicity from prior anti-tumor therapy, defined as not having
resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
grade 1, or to levels dictated in the eligibility criteria with the exception
of alopecia or toxicities from prior anti-tumor therapy that are considered
irreversible (defined as having been present and stable for > 21 day) which may
be allowed if they are not otherwise described in the exclusion criteria AND
there is agreement to allow by both the investigator and Amgen.
For more information, see section 5.2 of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary (Part 1 Only)<br /><br>• objective response (OR) (complete response [CR] and partial response [PR])<br /><br>• incidence of treatment-emergent adverse events (TEAEs)<br /><br>• serum concentrations of tarlatamab<br /><br><br /><br>Primary (All Parts)<br /><br>• OR (CR and PR)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary (All parts):<br /><br>1.<br /><br>• duration of response (DOR)<br /><br>• disease control (DC)<br /><br>• duration of DC<br /><br>• progression-free survival (PFS)<br /><br><br /><br>2.<br /><br>• OR<br /><br>• DOR<br /><br>• DC<br /><br>• duration of DC<br /><br>• PFS<br /><br>• overall survival (OS)<br /><br><br /><br>3.<br /><br>• incidence of TEAEs<br /><br><br /><br>4.<br /><br>• serum concentrations of tarlatamab<br /><br><br /><br>5.<br /><br>• incidence of anti-tarlatamab antibody formation</p><br>