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Clinical Trials List

Protocol NumberCAAA601A42101
NCT Number(ClinicalTrials.gov Identfier)NCT05142696
Completed

2025-04-04 - 2029-12-07

Phase I/II

Recruiting3

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    NOVARTIS (TAIWAN) CO., LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/14

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭小湘 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsi Kuo
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Extensive Stage Small Cell Lung Cancer

Objectives

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.

Test Drug

LUTATHERA® (AAA601)
NETSPOT® (AAA501)

Active Ingredient

AAA601 ([177Lu]Lu-DOTA-TATE)
AAA501 ([68Ga]Ga-DOTA-TATE)

Dosage Form

Solution for infusion
Injection

Dosage

370
40

Endpoints

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)

Inclution Criteria

Participant is >= 18 years on the day of signing informed consent form
Histologically or cytologically confirmed ES-SCLC
Presence of measurable disease
No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
ECOG status =< 1
Provision of tumor tissue to support exploratory biomarker analysis
Life expectancy of >= 6 months

Exclusion Criteria

Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
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

The Estimated Number of Participants

  • Taiwan

    7 participants

  • Global

    200 participants

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