NCT05142696|Active Not RecruitingPhase 1DMCFDA Drug

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

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

Novartis Pharmaceuticals ClinicalTrials.gov

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3 other identifiers

CAAA601A421012021-004155-162024-513185-19-00

Study Type

interventional

Target

Locations

16 countries

Sites

Timeline

RegisteredDec 2021

StartedJul 2022

CompletionMar 2029

Brief Summary

This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

35mo left

Started Jul 2022

Longer than P75 for phase_1

Geographic Reach

16 countries

40 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.7 years study duration

Study Progress57%

Jul 2022Mar 2029

First Submitted

Initial submission to the registry

November 15, 2021

Completed

17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed

7 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed

6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2029

Expected

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

November 15, 2021

Last Update Submit

March 16, 2026

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Extensive Stage Small Cell Lung CancerES-SCLCRadioligand therapyRLT[177Lu]Lu-DOTA-TATELutatheraLutetium (177Lu) oxodotreotideLutetium Lu 177 dotatateatezolizumabcarboplatinetoposide

Outcome Measures

Primary Outcomes (2)

Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of \[177Lu\]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment]
Phase ll: Overall survival (OS)
To assess efficacy of \[177Lu\]Lu-DOTA-TATE in combination with atezolizumab, carboplatin, and etoposide (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
In the phase II part: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)

Secondary Outcomes (12)

Phase lb: Objective Response Rate (ORR) based on Investigator assessment
From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Duration of Response (DOR)
From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Progression Free Survival (PFS) based on Investigator assessment
From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
Phase lb: Overall Survival (OS)
From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)
Phase ll: Progression free survival (PFS) by investigator assessment
From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
+7 more secondary outcomes

Study Arms (8)

Dose Level 1 (DL1)

EXPERIMENTAL

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.