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Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

NCT05815160•Debiopharm International SA

View on ClinicalTrials.gov

Summary

The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide. The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed SCLC
•2. Tumor that is not bleeding
•3. Prior platinum-based chemotherapy (carboplatin and/or cisplatin)
•* Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy
•* Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy
•4. Measurable disease per RECIST 1.1
•5. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available
•6. ECOG performance status of 0-1
•7. Life expectancy of at least 3 months in the best judgment of the Investigator
•8. Adequate bone marrow, hepatic and renal function, adequate coagulation status
+1 more criteria

Exclusion Criteria

•1. Use of an investigational agent or medical device within 28 days prior to first dose of study treatment.
•2. History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
•3. History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy.
•4. Left ventricular ejection fraction (LVEF) below 55%.
•5. QTcF \>450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP.
•6. Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs
•7. Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment.
•8. Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding.
•9. Radiographic findings of Interstitial lung disease (ILD) that are considered clinically significant.
•10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
+8 more criteria

Locations (13)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Hospital Universitario de A Coruna

A Coruña, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Institut Catala D'Oncologia - Badalona

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario HM Sanchinarro. START Madrid - Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, Spain

NEXT Oncology Madrid

Madrid, Spain

Key Dates

Start Date

May 2, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer Recurrent

Interventions

Debio 0123

DRUG

Etoposide

DRUG

Carboplatin

DRUG

Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial

NCT06848426

Non-Small Cell Lung CancerNon-small Cell Lung Cancer Recurrent+3 more

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NOT_YET_RECRUITINGPHASE2

Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

NCT06648200

Small Cell Lung Cancer Extensive StageSmall Cell Lung Cancer Recurrent

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

Inclusion Criteria

Exclusion Criteria

Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial

Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

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