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New treatment option for Relapsed Small Cell Lung Cancer
Official title Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
ClinicalTrials.gov ID: NCT06681220
What this study is testing
What is Stenoparib/Temozolomide?
Stenoparib/Temozolomide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed small cell lung cancer.
Also referred to as Stenoparib/TEMODAR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the...
- Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic...
- Prior exposure to lurbinectedin, TMZ or stenoparib.
- Pregnant or breastfeeding.
- Clinical significant cardiovascular disease (ie active)
- Subject with known hypersensitivity to Stenoparib components
See the full eligibility 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:
- ANC 1.5
- Platelets 100 × 109/L
- Hemoglobin 9 g/dL or 5.6 mmol/L
- Aspartate transaminase and alanine transaminase 2.5 × upper limit of normal (ULN), \<5× in patients with known liver metastases
- Serum total bilirubin 1.5 × ULN, 1.5-3.0 × ULN may be included appropriate starting dose adjustment to 200 mg daily.
- Creatinine \<1.5 × ULN or estimated glomerular filtration rate (GFR) 50 ml/min by Cockcroft-Gault. Depending on scenario, GFR 30-49 can be --permissible.
- Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test within 72 hours of cycle 1 Day 1.
- Male and female people of child-bearing potential must agree to use a double-barrier method of birth control from the screening visit through 180 days after the last dose of study drug.
- Male people of child-bearing potential must agree to use a double-barrier method of birth control including use a male condom (and should also be advised of the benefit for a female partner to use a highly effective...
- Previously treated or asymptomatic brain metastases are allowed.
- Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with...
- Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: people with HIV/AIDS with adequate antiviral...
- Prior exposure to lurbinectedin, TMZ or stenoparib.
- Pregnant or breastfeeding.
- Clinical significant cardiovascular disease (ie active)
- Subject with known hypersensitivity to Stenoparib components
- Subject with known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) are excluded.
- Subject with QTc interval 470 for females, or 450 for males per electrocardiogram (EKG) at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Salisbury, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; Louisville, Kentucky, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.