← Back to Search

Radioisotope Therapy

Lu-DOTA-TATE + Chemotherapy + Immunotherapy for Small Cell Lung Cancer

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake in at least one target or non-target lesion
Histologically or cytologically confirmed ES-SCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until date of death from any cause, assessed up to 3 years (estimated final overall survival (os) analysis)
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test a combination of drugs for ES-SCLC. It will check safety and how well it is tolerated.

Who is the study for?
This trial is for adults over 18 with newly diagnosed ES-SCLC who haven't had treatment yet. They need a positive PET scan showing SSTR and at least one measurable tumor lesion. People can't join if they have brain metastasis, autoimmune diseases, severe infections, recent major surgery, ECG abnormalities that pose risks, known drug hypersensitivity or are in another clinical study.Check my eligibility
What is being tested?
The study tests the safety of [177Lu]Lu-DOTA-TATE combined with carboplatin, etoposide, and tislelizumab as initial treatment for ES-SCLC. It also looks at using tislelizumab alone as ongoing maintenance therapy after the first treatments.See study design
What are the potential side effects?
[177Lu]Lu-DOTA-TATE may cause radiation-related side effects like nausea and fatigue. Tislelizumab can lead to immune-related issues such as inflammation in organs. Carboplatin and etoposide might result in low blood cell counts increasing infection risk and causing tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My scan shows at least one cancer spot is SSTR positive.
Select...
My cancer is confirmed as small cell lung cancer through a biopsy.
Select...
I can provide a sample of my tumor for further testing.
Select...
I am 18 years old or older.
Select...
I have not received any systemic treatment for small cell lung cancer.
Select...
I have at least one tumor that can be measured on a CT scan.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until date of death from any cause, assessed up to 3 years (estimated final overall survival (os) analysis)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of death from any cause, assessed up to 3 years (estimated final overall survival (os) analysis) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of dose limiting toxicities (DLTs)
Secondary outcome measures
Absorbed radiation doses of [177Lu]Lu-DOTA-TATE
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [177Lu]Lu-DOTA-TATE
Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-DOTA-TATE
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose Level 4 (DL4)Experimental Treatment5 Interventions
Dose Level 4 (DL4): [177Lu]Lu-DOTA-TATE 250 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Group II: Dose Level 3b (DL3b)Experimental Treatment5 Interventions
Dose Level 3b (DL3b): [177Lu]Lu-DOTA-TATE 200 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Group III: Dose Level 3a (DL3a)Experimental Treatment5 Interventions
Dose Level 3a (DL3a): [177Lu]Lu-DOTA-TATE 200 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Group IV: Dose Level 2b (DL2b)Experimental Treatment5 Interventions
Dose Level 2b (DL2b): [177Lu]Lu-DOTA-TATE 150 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Group V: Dose Level 2a (DL2a)Experimental Treatment5 Interventions
Dose Level 2a (DL2a): [177Lu]Lu-DOTA-TATE 150 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 150 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Group VI: Dose Level 1 (DL1)Experimental Treatment5 Interventions
Dose Level 1 (DL1): [177Lu]Lu-DOTA-TATE 100 mCi Q6W with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 Q3W, and tislelizumab 200 mg Q3W in induction period, then [177Lu]Lu-DOTA-TATE 100 mCi Q3W plus Tislelizumab 200 mg Q3W in the maintenance period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4490

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,844 Previous Clinical Trials
4,193,453 Total Patients Enrolled

Media Library

[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05142696 — Phase 1
Small Cell Lung Cancer Research Study Groups: Dose Level 2b (DL2b), Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 3a (DL3a), Dose Level 4 (DL4), Dose Level 3b (DL3b)
Small Cell Lung Cancer Clinical Trial 2023: [177Lu]Lu-DOTA-TATE Highlights & Side Effects. Trial Name: NCT05142696 — Phase 1
[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142696 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are currently employing this clinical trial?

"At this time, the clinical trial is recruiting participants at 9 sites around the world. These locations include Cleveland, Barcelona and Malaga in addition to other cities. To lessen your travel burden as a participant, we suggest selecting the closest clinic location possible."

Answered by AI

What is the maximum sample size of this clinical trial?

"As per the inclusion criteria, this clinical trial requires 39 participants. These eligible patients can receive treatment at various locations such as University Hospitals of Cleveland in Ohio or Novartis Investigative Site located in Barcelona, Catalunya."

Answered by AI

Are there any similar studies that have utilized Dose Level 1 (DL1)?

"The first iteration of Dose Level 1 (DL1) was trialled back in 2014 at the Cross Cancer Institute. Subsequently, there have been 555 conducted studies with 137 presently ongoing clinical trials, particularly in Cleveland, Ohio."

Answered by AI

Has the FDA given its sanction to Dose Level 1 (DL1)?

"With limited clinical data demonstrating DL1's efficacy or safety, our team assigned it a rating of 1 on the three-point scale."

Answered by AI

Is there any available enrollment capacity for participants in this trial?

"Based on the information available, this medical trial is still in need of participants. The initial posting was made public on July 13th 2022 and most recently updated on March 13th 2023."

Answered by AI
~17 spots leftby May 2025