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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

Must not have

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

Active leptomeningeal disease or uncontrolled, untreated brain metastasis

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe infections needing strong antibiotics or antivirals recently.

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I do not have untreated brain cancer spread or active spinal cord cancer.

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I have heart issues that could make participating in the study unsafe.

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I have been treated with drugs that target the immune system.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860

0 / 10Eligibility criteria met