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NCT05142696 | RECRUITING | Extensive Stage Small Cell Lung Cancer

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

Novartis Pharmaceuticals

Brief Summary:

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.

Condition or disease

Extensive Stage Small Cell Lung Cancer

Intervention/treatment

[177Lu]Lu-DOTA-TATE

Atezolizumab

[68Ga]Ga-DOTA-TATE

Carboplatin

Etoposide

Phase

PHASE1

PHASE2

Detailed Description:

The study for each participant consists of a Screening period, a Treatment period that includes an Induction treatment period and a Maintenance treatment period, and a Follow-up period. The study will consist of a Phase Ib dose escalation with concurrent backfill part and a randomised controlled Phase II part. During the screening period of up to 28 days before starting SCLC treatment, each participant will be assessed for somatostatin receptor (SSTR) expression by \[68Ga\]Ga-DOTA-TATE imaging PET/scan. The dose escalation part in this study will be guided by the dose limiting toxicity (DLT) rate observed during the DLT period. To achieve a more robust dataset and to aid dose decisions, additional participants may be backfilled in each dose level. Upon declaring RD, a 1:1 randomised Phase II with approximately 140 participants with newly diagnosed ES-SCLC will be enrolled and receive either \[177Lu\]Lu-DOTA-TATE at the RD in combination with carboplatin, etoposide and atezolizumab (experimental arm) or carboplatin, etoposide and atezolizumab alone (control arm).

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-07-13
Estimated Primary Completion Date : 2029-03-09
Estimated Study Completion Date : 2029-03-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion 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 demonstrating moderate or higher uptake of \[68Ga\]Ga-DOTA-TATE on PET imaging; in case of liver involvement, at least one liver lesion \> = 1 cm
  • * 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
  • Key Exclusion Criteria
    • * 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
    • * Prior administration of therapeutic radiopharmaceuticals
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

Location Details

NCT05142696

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

Georgetown University Lombardi Cancer Center

Washington, District of Columbia, United States, 20007 2197

RECRUITING

United States, Georgia

University Cancer and Blood Center LLC

Athens, Georgia, United States, 30607

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

RECRUITING

United States, Missouri

St. Louis University

Saint Louis, Missouri, United States, 63104

RECRUITING

United States, New Jersey

Hackensack Meridian Health

Edison, New Jersey, United States, 88837

RECRUITING

United States, Ohio

University Hospitals Of Cleveland

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

RECRUITING

Austria, Tyrol

Novartis Investigative Site

Innsbruck, Tyrol, Austria, 6020

RECRUITING

Canada, Quebec

Novartis Investigative Site

Montreal, Quebec, Canada, H2W 1T8

RECRUITING

Canada, Quebec

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1E2

RECRUITING

France,

Novartis Investigative Site

Bron, France, 69677

RECRUITING

France,

Novartis Investigative Site

Lille, France, 59000

RECRUITING

France,

Novartis Investigative Site

Marseille, France, 13885

RECRUITING

France,

Novartis Investigative Site

Montpellier, France, 34298

RECRUITING

France,

Novartis Investigative Site

Villejuif, France, 94800

RECRUITING

Germany,

Novartis Investigative Site

Essen, Germany, 45147

RECRUITING

Germany,

Novartis Investigative Site

Cologne, Germany, 50937

RECRUITING

Hong Kong,

Novartis Investigative Site

Hong Kong, Hong Kong, 999077

RECRUITING

Israel,

Novartis Investigative Site

Haifa, Israel, 3109601

RECRUITING

Israel,

Novartis Investigative Site

Tel Aviv, Israel, 6423906

RECRUITING

Italy,

Novartis Investigative Site

Napoli, Italy, 80131

RECRUITING

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 05505

RECRUITING

Singapore,

Novartis Investigative Site

Singapore, Singapore, 168583

RECRUITING

Spain, Catalonia

Novartis Investigative Site

Barcelona, Catalonia, Spain, 08035

RECRUITING

Spain,

Novartis Investigative Site

Madrid, Spain, 28009

RECRUITING

Spain,

Novartis Investigative Site

Madrid, Spain, 28040

RECRUITING

Spain,

Novartis Investigative Site

Madrid, Spain, 28041

RECRUITING

Spain,

Novartis Investigative Site

Malaga, Spain, 29010

RECRUITING

Taiwan,

Novartis Investigative Site

Taipei, Taiwan, 103616

RECRUITING

United Kingdom, Surrey

Novartis Investigative Site

Guildford, Surrey, United Kingdom, GU2 7XX