Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

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Primary Purpose

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

Tarlatamab

About this trial

This is an expanded access trial for Small Cell Lung Cancer focused on measuring Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology, Delta-like ligand 3

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Age ≥ 18 years Histologically or cytologically confirmed SCLC Extensive-stage, unable to be encompassed in a tolerable radiation plan Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 Minimum life expectancy of 12 weeks Exclusion Criteria: Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology Untreated or symptomatic central nervous system (CNS) metastases Active hepatitis B or hepatitis C virus infection Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product Currently or previously enrolled in a prior tarlatamab study Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT06064500

First Posted

September 26, 2023

Last Updated

September 26, 2023

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT06064500

Brief Title

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Official Title

A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Study Type

Expanded Access

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

Brief Summary

The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology, Delta-like ligand 3

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tarlatamab

Other Intervention Name(s)

AMG 757

Intervention Description

Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Histologically or cytologically confirmed SCLC Extensive-stage, unable to be encompassed in a tolerable radiation plan Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 Minimum life expectancy of 12 weeks Exclusion Criteria: Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology Untreated or symptomatic central nervous system (CNS) metastases Active hepatitis B or hepatitis C virus infection Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product Currently or previously enrolled in a prior tarlatamab study Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amgen Call Center

Phone

866-572-6436

Email

medinfo@amgen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MD

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial