NCT06681220 · VA Office of Research and Development
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
(Relapsed SCLC)
What this study is about
randomly assigned phase 2, conducted at multiple hospitals, biomarker directed clinical trial with a safety lead-in to assess the effectiveness of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients.
View original scientific description
Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxicity period will be 1 cycle of 21 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older at the time of consent.
- Histological or cytological diagnosis of extensive-stage small cell lung cancer.
- Patients must have received one prior line of systemic therapy.
- Patients must have received first-line therapy with Carboplatin and Etoposide.
- If patient is re-treated with Carboplatin and Etoposide at least 6 months or more after first regimen, this will still be considered one line of
- treatment and they will qualify for this trial.
- Patients could have received immunotherapy in combination with the chemotherapy regimen.
- Patients who have received Tarlatamab as second line treatment are allowed.
- ECOG Performance status 0-2.
- Measurable disease as per RECIST v1.1 (NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation).
- Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:
Where
- Palo Alto, California
- Chicago, Illinois
- Indianapolis, Indiana
- Louisville, Kentucky
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Omaha, Nebraska
- Salisbury, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations