Active — Not RecruitingPhase 2

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

United States222 participantsStarted 2021-12-01

Plain-language summary

The main aim of this study is to: * evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] by investigator) of 2 dose levels of tarlatamab for Part 1 only * evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2 * evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
✕. End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab.

What they're measuring

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

Timeframe: Up to a maximum of 61 months

Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events

Timeframe: Up to a maximum of 61 months

Part 1 Only: Serum Concentrations of Tarlatamab

Timeframe: Up to a maximum of 24 months

Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Timeframe: Up to a maximum of 61 months

Trial details

NCT IDNCT05060016

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Relapsed/Refractory Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines.
✕. End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab.

What they're measuring

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator

Timeframe: Up to a maximum of 61 months

Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events

Timeframe: Up to a maximum of 61 months

Part 1 Only: Serum Concentrations of Tarlatamab

Timeframe: Up to a maximum of 24 months

Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)

Timeframe: Up to a maximum of 61 months