First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Sponsor

Amgen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05361395

Collaborator

(none)

208

Enrollment

Arms

27.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Drug: Tarlatamab Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Dose Exploration Combination Regimen 1 Tarlatamab+Atezolizumab+Carboplatin+Etoposide	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq
Experimental: Part 2: Dose Exploration Combination Regimen 2 Tarlatamab+Atezolizumab+Carboplatin+Etoposide	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq
Experimental: Part 3: Dose Exploration Combination Regimen 3 Tarlatamab+Atezolizumab+Carboplatin+Etoposide	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq
Experimental: Part 4: Dose Expansion Dose Expansion of either Combination Regimen 1,2,or 3	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq
Experimental: Part 5: Dose Exploration Maintenance Tarlatamab+Atezolizumab	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq
Experimental: Part 6: Dose Expansion Maintenance Expansion of selected dose from Part 5	Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Other Names: AMG 757 Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion. Other Names: Tecentriq

Outcome Measures

Primary Outcome Measures

Number of Participants with a Dose Limiting Toxicity (DLT) [24 months]
Number of Participants with Treatment-emergent Adverse Events (TEAE) [24 months]
Number of Participants with Treatment-related Adverse Events [24 months]
Number of Participants with Clinically Significant Changes in Vital Signs [24 months]
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements [24 months]
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [24 months]

Secondary Outcome Measures

6-month Progression-free Survival (PFS) [24 months]
Objective Response (OR) [24 months]
Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Duration of Response (DOR) [24 months]
Disease Control Rate(DCR) [24 months]
Overall Survival (OS) [24 months]
Serum Concentration of Tarlatamab [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant has provided informed consent 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.
Histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC
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.

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.
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.
History of immune-related colitis.
History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
History of solid organ transplantation.
History of hypophysitis or pituitary dysfunction.
Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.