ACTIVE_NOT_RECRUITING

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

Conditions

Extensive Stage Small Cell Lung Cancer ES-SCLC Radioligand therapy RLT [177Lu]Lu-DOTA-TATE Lutathera Lutetium (177Lu) oxodotreotide Lutetium Lu 177 dotatate atezolizumab carboplatin etoposide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-13

Study Completion:2029-03-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05142696

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.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant is \>= 18 years on the day of signing informed consent form * Histologically or cytologically confirmed ES-SCLC * Presence of measurable disease * 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

Inclusion Criteria

Exclusion Criteria

* Participant is \>= 18 years on the day of signing informed consent form
* Histologically or cytologically confirmed ES-SCLC
* Presence of measurable disease
* 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

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Georgetown University Lombardi Cancer Center

Washington D.C., District of Columbia, 20007 2197

United States

Advent Health Cancer Institute

Orlando, Florida, 32804

United States

University Cancer and Blood Center LLC

Athens, Georgia, 30607

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

St. Louis University

St Louis, Missouri, 63104

United States

Hackensack Meridian Health

Edison, New Jersey, 88837

United States

University Hospitals Of Cleveland

Cleveland, Ohio, 44106

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Vanderbilt University Medical Ctr

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13

Study Completion Date2029-03-23

Study Record Updates

Study Start Date2022-07-13

Study Completion Date2029-03-23

Terms related to this study

Keywords Provided by Researchers

Extensive Stage Small Cell Lung Cancer
ES-SCLC
Radioligand therapy
RLT
[177Lu]Lu-DOTA-TATE
Lutathera
Lutetium (177Lu) oxodotreotide
Lutetium Lu 177 dotatate
atezolizumab
carboplatin
etoposide

Additional Relevant MeSH Terms

Extensive Stage Small Cell Lung Cancer