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

Conditions

• Relapsed/Refractory Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tarlatamab — DRUG
  Intravenous (IV) infusion

Study Details

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

Key Dates

Start date

Dec 1, 2021

Status verified

Dec 2025

Primary completion

Dec 30, 2026

Completion

Dec 30, 2027

Study Design

Enrollment

222 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Tarlatamab Low Dose
  Participants will receive the low dose of Tarlatamab.
• Experimental: Part 1: Tarlatamab High Dose
  Participants will receive the high dose of Tarlatamab.
• Experimental: Part 2: Dose Expansion
  Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.
• Experimental: Part 3: Modified Monitoring Substudy
  Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.

Primary Outcome Measure

Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator [ Time Frame: Up to a maximum of 61 months ]

Locations (16)

Find similar trials in Birmingham, AL

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