A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

Description

This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.

Conditions

Extensive Stage Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.

A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase

A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

Condition
Extensive Stage Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Georgetown University Lombardi Cancer Center, Washington, District of Columbia, United States, 20007 2197

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Cleveland

University Hospitals Of Cleveland, Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant is \>= 18 years on the day of signing informed consent form
  • * Histologically or cytologically confirmed ES-SCLC
  • * Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
  • * No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
  • * ECOG status =\< 1
  • * Provision of tumor tissue to support exploratory biomarker analysis
  • * Life expectancy of \>= 6 months
  • * Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
  • * Active autoimmune diseases or history of autoimmune diseases that may relapse
  • * Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
  • * Any major surgical procedure requiring general anesthesia =\< 28 days before Cycle 1 Day 1
  • * History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
  • * Known hypersensitivity to the active substances or any of the excipients of the study drugs
  • * Concurrent participation in another therapeutic clinical study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2029-06-01