JPRN-jRCT2031220086
Active, not recruiting
Phase 1
A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Tagashira Shuzo0 sites50 target enrollmentMay 25, 2022
ConditionsSmall Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Tagashira Shuzo
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
- •2\. Age greater than or equal to 18 years old at the same time of signing the informed consent
- •3\. Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum\-based regimen
- •4\. Eastern Cooperative Oncology Group (ECOG) 0 to 1
- •5\. Participants with treated brain metastases are eligible provided they meet defined criteria
- •6\. Adequate organ function as defined in protocol
Exclusion Criteria
- •1\. History of other malignancy within the past 2 years with exceptions
- •2\. Major surgery within 28 days of first dose of tarlatamab
- •3\. Untreated or symptomatic brain metastases and leptomeningeal disease
- •4\. Prior anti\-cancer therapy, including anti\-PD1 or anti\-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti\- cancer therapy and the first planned dose of tarlatamab
- •Exceptions:
- •\- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment\-related toxicity resolved to grade \<\= 1\.
- •\- Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab
- •5\. Participants who received prior tarlatamab therapy or prior delta\-like ligand 3 (DLL3\) x cluster of differentiation 3 (CD3\) bispecific therapy are not eligible
- •6\. Participants who experienced recurrent grade 2 pneumonitis or severe or life\-threatening immune\-mediated adverse events or infusion\-related reactions including those that lead to permanent discontinuation while on treatment with immuno\-oncology agents
- •7\. History of any immune\-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis
Outcomes
Primary Outcomes
Not specified
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