A Safety Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) Patients in Combination With Carboplatin, Etoposide and Tislelizumab

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

ClinicalTrials.gov Identifier: NCT05142696

Novartis Reference Number: CAAA601A42101

Last Update: Nov 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and tislelizumab in induction treatment and with tislelizumab in maintenance treatment in newly diagnosed patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

Condition 
Extensive Stage Small Cell Lung Cancer
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Jul 13, 2022
Completion date 
Mar 27, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

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
Tislelizumab
Tislelizumab 200 mg on Day 1 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

Eligibility 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 assessed by conventional computed tomography (CT) scan
SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake in at least one target or non-target lesion
No prior systemic treatment for ES-SCLC
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 leptomeningeal disease or uncontrolled, untreated brain metastasis
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

Study Locations

France
Novartis Investigative Site
Recruiting
Lille, 59000
-
France
Novartis Investigative Site
Recruiting
Marseille Cedex 05, 13885
-
France
Novartis Investigative Site
Recruiting
Montpellier, 34298
-
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94800
-
France
Spain
Novartis Investigative Site
Recruiting
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]