Combination of Debio 0123 with Carboplatin and Etoposide for Recurrent Small Cell Lung Cancer
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
This study is testing a new drug called Debio 0123 combined with carboplatin and etoposide to see if it is safe and effective for adults with recurrent small cell lung cancer who have already had platinum-based treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Debiopharm International SA Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 15 sites (Little Rock, Arkansas and 14 other locations) |
| Trial ID | NCT05815160 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of Debio 0123 when used in combination with carboplatin and etoposide in adults with recurrent small cell lung cancer (SCLC) who have previously undergone platinum-based therapy. The study consists of two parts: the first part focuses on dose escalation to determine the recommended dose, while the second part involves dose expansion to further assess safety at that recommended dose. Participants will undergo tumor biopsies and will be monitored for their response to the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with histologically confirmed recurrent small cell lung cancer who have previously received platinum-based chemotherapy.
Not a fit: Patients who have not received prior platinum-based chemotherapy or those with bleeding tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with recurrent small cell lung cancer.
How similar studies have performed: While there have been studies exploring combinations of chemotherapy agents for small cell lung cancer, the specific use of Debio 0123 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 9. Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures. 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. 11. Any infection requiring the systemic use of an antibiotic or antiviral agent. 12. Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV) infection. Participants with past infections that have been cured may be enrolled. 13. Immunization with live or live-attenuated vaccine within 28 days prior to first dose of study treatment. 14. Inability or unwillingness to swallow oral medications. 15. Chemotherapy, monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to first dose of study treatment. Palliative radiation is allowed up to 1 week prior to study treatment start. 16. Unresolved AEs or toxicities due to previous treatments \>Grade 1. Note: Participants with ≤Grade 2 alopecia or endocrinopathies controlled by replacement therapy are exceptions and may qualify for the study. 17. Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior hypersensitivity to carboplatin has been observed but a successful desensitization was performed for the participant, he or she may be eligible for the study. 18. Prior exposure to any WEE1 inhibitor Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Where this trial is running
Little Rock, Arkansas and 14 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Institut Catala D'Oncologia - Badalona — Barcelona, Spain (Recruiting)
- Hospital Universitario de A Coruna — Coruña, Spain (Recruiting)
- Hospital General Universitario Gregorio Maranon — Madrid, Spain (Recruiting)
- Clinica Universidad de Navarra — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario HM Sanchinarro. START Madrid - Centro Integral Oncológico Clara Campal (CIOCC) — Madrid, Spain (Recruiting)
- NEXT Oncology Madrid — Madrid, Spain (Recruiting)
- Hospital Quironsalud Malaga — Málaga, Spain (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Spain (Recruiting)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Debiopharm International S.A
- Email: clinicaltrials@debiopharm.com
- Phone: +41 21 321 01 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.