A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer

A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer - 20200469 (DeLLphi-303)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53561

Enrollment

Registered

2022-04-04

Start date

2023-01-02

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kleincellig longkanker extensive stage small cell lung cancer lung cancer

Interventions

Tarlatamab will be evaluated - in combination with chemo-immunotherapy followed by maintenance cycles of tarlatamab plus PD-L1 inhibitor, and - as maintenance only in combination with tarlatamab plus

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures • Age greater than or equal to 18 years old at the same time of signing the informed consent • Participants with histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC other than protocol defined standard of care first line therapy prior to enrollment. Subjects with prior treatment for limited stage SCLC (LS-SCLC) are permitted. • Eastern Cooperative Oncology Group (ECOG) 0 to 1 • Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria • Adequate organ function as defined in protocol Please refer to section 5.1 of the protocol for the full list of inclusion criteria and any changes in these following protocol amendment 3.

Exclusion criteria

Exclusion criteria: • History of other malignancy within the past 2 years with exceptions • Major surgery within 28 days of study day 1 • Untreated or symptomatic brain metastases and leptomeningeal disease Please refer to section 5.2 of the protocol for the full list of exclusion criteria and any changes in these following protocol amendment 3.

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities (DLTs), treatment-emergent and treatment-related adverse events, changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests.	—

Secondary

Measure	Time frame
- Progression free survival, will be based on modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). - Objective response, based on modified RECIST v1.1 - Duration Of Response, and Disease control, as per modified RECIST v1.1. - Overall survival (OS) as per modified RECIST v1.1 - Serum concentrations of tarlatamab.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)