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Radioisotope Therapy

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

Phase 1 & 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan

Participant is >= 18 years on the day of signing informed consent form

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

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

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I have at least one tumor that can be measured on a CT scan.

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I am 18 years old or older.

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My scan shows at least one cancer spot is SSTR positive.

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My cancer is confirmed as small cell lung cancer through a biopsy.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have not received any systemic treatment for small cell lung cancer.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation

Phase ll: Overall survival (OS)

Secondary outcome measures

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

Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs) within 48 hours after [68Ga]Ga-DOTA-TATE administration

+18 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Phase II Experimental armExperimental Treatment4 Interventions

[177Lu]Lu-DOTA-TATE at recommended dose declared in phase I part in combination with carboplatin, etoposide and atezolizumab (experimental arm)

Group II: Phase II Control armExperimental Treatment4 Interventions

Carboplatin, etoposide and atezolizumab alone (control arm)

Group III: Dose Level 4 (DL4)Experimental Treatment5 Interventions

Dose Level 4 (DL4): [177Lu]Lu-DOTA-TATE 250 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period.

Group IV: Dose Level 3b (DL3b)Experimental Treatment5 Interventions

Dose Level 3b (DL3b): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period.

Group V: Dose Level 3a (DL3a)Experimental Treatment5 Interventions

Dose Level 3a (DL3a): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 mg in the maintenance period.

Group VI: Dose Level 2b (DL2b)Experimental Treatment5 Interventions

Dose Level 2b (DL2b): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumad 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 in the maintenance period.

Group VII: Dose Level 2a (DL2a)Experimental Treatment5 Interventions

Dose Level 2a (DL2a): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 150 mCi plus atezolizumab 1200 mg in the maintenance period.

Group VIII: Dose Level 1 (DL1)Experimental Treatment5 Interventions

Dose Level 1 (DL1): [177Lu]Lu-DOTA-TATE 100 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 100 mCi plus atezolizumab 1200 mg in the maintenance period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,270 Total Patients Enrolled

Media Library

[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05142696 — Phase 1 & 2

Small Cell Lung Cancer Research Study Groups: Phase II Experimental arm, Phase II Control arm, Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 4 (DL4)

Small Cell Lung Cancer Clinical Trial 2023: [177Lu]Lu-DOTA-TATE Highlights & Side Effects. Trial Name: NCT05142696 — Phase 1 & 2

[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142696 — Phase 1 & 2

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

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142696.

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