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Clinical Trials List

Protocol NumberCAAA601A42101
NCT Number(ClinicalTrials.gov Identfier)NCT05142696
Not yet recruiting

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

    2026/02/01

Investigators and Locations

Principal Investigator Gee-chen Chang 無
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

Infusion Solution
injection

Dosage

30 MBq/mL
40 mcg

Endpoints

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)

Inclution Criteria

Key Inclusion 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

Key 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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