NCT05142696 - A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

July 13, 2022

Primary Completion Date

March 9, 2029

Study Completion Date

March 23, 2029

Conditions

Extensive Stage Small Cell Lung Cancer

Interventions

DRUG

[177Lu]Lu-DOTA-TATE

"Solution for infusion of \[177Lu\]Lu-DOTA-TATE will be administered as follows:~* 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3~* 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed"

DRUG

Atezolizumab

Atezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period

DRUG

[68Ga]Ga-DOTA-TATE

2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)

OTHER

Carboplatin

Four cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period

OTHER

Etoposide

Four cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period

Trial Locations (47)

3813

RECRUITING

Novartis Investigative Site, Amersfoort

6020

RECRUITING

Novartis Investigative Site, Innsbruck

13885

RECRUITING

Novartis Investigative Site, Marseille

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

20133

RECRUITING

Novartis Investigative Site, Milan

28009

RECRUITING

Novartis Investigative Site, Madrid

28040

RECRUITING

Novartis Investigative Site, Madrid

28041

RECRUITING

Novartis Investigative Site, Madrid

29010

RECRUITING

Novartis Investigative Site, Málaga

30607

RECRUITING

University Cancer and Blood Center LLC, Athens

32804

RECRUITING

Advent Health Cancer Institute, Orlando

33305

RECRUITING

Novartis Investigative Site, Taoyuan District

34298

RECRUITING

Novartis Investigative Site, Montpellier

37007

RECRUITING

Novartis Investigative Site, Salamanca

40201

RECRUITING

Novartis Investigative Site, Taichung

40536

RECRUITING

University of Kentucky, Lexington

44093

RECRUITING

Novartis Investigative Site, Nantes

44106

RECRUITING

University Hospitals Of Cleveland, Cleveland

45147

RECRUITING

Novartis Investigative Site, Essen

50937

RECRUITING

Novartis Investigative Site, Cologne

59000

RECRUITING

Novartis Investigative Site, Lille

63104

RECRUITING

St. Louis University, St Louis

69677

RECRUITING

Novartis Investigative Site, Bron

80131

RECRUITING

Novartis Investigative Site, Napoli

88837

RECRUITING

Hackensack Meridian Health, Edison

94800

RECRUITING

Novartis Investigative Site, Villejuif

100036

RECRUITING

Novartis Investigative Site, Beijing

103616

RECRUITING

Novartis Investigative Site, Taipei

168583

RECRUITING

Novartis Investigative Site, Singapore

200032

RECRUITING

Novartis Investigative Site, Shanghai

999077

RECRUITING

Novartis Investigative Site, Hong Kong

3109601

RECRUITING

Novartis Investigative Site, Haifa

5265601

RECRUITING

Novartis Investigative Site, Ramat Gan

6423906

RECRUITING

Novartis Investigative Site, Tel Aviv

8457108

RECRUITING

Novartis Investigative Site, Beersheba

20007 2197

RECRUITING

Georgetown University Lombardi Cancer Center, Washington D.C.

A 4020

RECRUITING

Novartis Investigative Site, Linz

A-1090

RECRUITING

Novartis Investigative Site, Vienna

M5G 2M9

RECRUITING

Novartis Investigative Site, Toronto

H2W 1T8

RECRUITING

Novartis Investigative Site, Montreal

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

779 00

RECRUITING

Novartis Investigative Site, Olomouc

3543 AZ

RECRUITING

Novartis Investigative Site, Utrecht

03722

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

08035

RECRUITING

Novartis Investigative Site, Barcelona

GU2 7XX

RECRUITING

Novartis Investigative Site, Guildford