Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults whose small cell lung cancer has spread widely and come back after treatment. It compares stenoparib plus temozolomide with the usual treatment, lurbinectedin, and checks safety. It also tests whether blood markers can help predict who may benefit from the drug combination.
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. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of Stenoparib with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). The study will include 9 participants for the safety evaluation of the Stenoparib+TMZ group and 5 participants for the standard of care Lurbinectedin safety group. We will first determine safety dose for the experiment arm which, will include 3 groups with 3 participants in each group. Three doses of Stenoparib will be evaluated for toxicity. The initial starting dose of Stenoparib will be 200mg po QD. Once the maximum tolerated dose has been determined, participants will be assigned to one of the two groups in the phase 2 portion. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Stenoparib plus Temozolomide (TMZ) or Lurbinectedin.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 18 and have confirmed small cell lung cancer that has spread widely.
- Your first treatment must have included carboplatin and etoposide, with or without immune treatment. Repeat treatment at least 6 months later still counts as one treatment. Tarlatamab as a second treatment is allowed.
- You must be able to care for yourself and be out of bed for at least half of your waking hours.
- Your cancer must be measurable. Cancer in an area treated with radiation must have grown since that treatment.
- Your blood counts, liver, and kidneys must meet the study's test requirements.
- If you can become pregnant, you must not be pregnant or breastfeeding and must have a negative pregnancy test within 72 hours before treatment starts.
- If you or your partner could become pregnant, you must use two barrier birth control methods from screening through 180 days after the last dose. Men must use a condom and not donate sperm through at least 90 days after the last dose.
- Cancer that has spread to the brain is allowed if it was treated before or causes no symptoms.
Who can't join
- A serious or unstable health condition, mental illness, or social situation that could make the study unsafe or hard to follow.
- A serious active infection needing medicine that works throughout the body. Controlled long-term infections, such as HIV or hepatitis, may be allowed.
- Past treatment with lurbinectedin, temozolomide, or stenoparib.
- Pregnancy or breastfeeding.
- Serious active heart or blood vessel disease.
- A known allergy to any part of stenoparib.
- A history of myelodysplastic syndrome, a disorder of blood-forming cells, or acute myeloid leukemia, a blood cancer.
- A heart rhythm test result that meets the study's QTc exclusion rule. QTc measures part of the heartbeat's electrical timing.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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: * 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 subjects 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 subjects 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 method of contraception as a condom may break or leak) and must agree to refrain from donating sperm from screening visit through at least 90 days after the last dose of study drug. * Previously treated or asymptomatic brain metastases are allowed. Exclusion Criteria: * 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 the protocol. * Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.) * 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.
Study sites (11)
CA
- VA Palo Alto Health Care System, Palo Alto, CA · Palo Alto, CA 94304-1207Millie Das, MD · Study contact · 650-493-5000 ext. 66133 · Millie.Das@va.govNiko Del Mar, RA · Study contact · 6504935000 ext. 65610 · niko.delmar@va.govMore trials in Palo Alto
IL
- Jesse Brown VA Medical Center, Chicago, IL · Chicago, IL 60612Larry Feldman, MD · Study contact · 312-569-5385 · lawrence.feldman@va.govAlicia Hulbert, MD · Study contact · 3124138878 · alicia.hulbert@va.govMore trials in Chicago
IN
- Richard L. Roudebush VA Medical Center, Indianapolis, IN · Indianapolis, IN 46202-2884Shadia Jalal, MD · Study contact · 317-274-5500 · Shadia.Jalal@va.govAleksandra Radovanovich, RN · Study contact · (317) 988-3338 · aleksandra.radovanovich@va.govShadia Jalal, MD · Principal investigatorMore trials in Indianapolis
KY
- Robley Rex VA Medical Center, Louisville, KY · Louisville, KY 40206-1433Fred Hendler, MD · Study contact · 502-287-4000 · Fred.Hendler@va.govDenise Zellars, MHA · Study contact · 5022875222 · Denise.Zellars@va.govMore trials in Louisville
MI
- VA Ann Arbor Healthcare System, Ann Arbor, MI · Ann Arbor, MI 48105-2303Nithya Ramnath,, MD · Study contact · 734-845-5800 · nithya.ramnath@va.govKelsey Bollin, BSN · Study contact · (734) 8453966 · Kelsey.Bollin@va.govMore trials in Ann Arbor
MN
- Minneapolis VA Health Care System, Minneapolis, MN · Minneapolis, MN 55417-2309Mark Klein, MD · Study contact · 612-467-4682 · Mark.Klein2@va.govJasmeen Chauhan, BA · Study contact · 6124674682 · Jasmeen.Chauhan@va.govMore trials in Minneapolis
NC
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC · Salisbury, NC 28144Jimmy Ruiz, MD · Study contact · 704-638-9000 · Jimmy.Ruiz@va.govTravis Gallimore, RC · Study contact · (704) 6389000 ext. 14419 · Travis.Gallimore@va.govMore trials in Salisbury
NE
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE · Omaha, NE 68105-1850Apar Ganti, MD · Study contact · 402-346-8800 · aparkishor.ganti@va.govAnna Kellogg, MS · Study contact · 4029954143 · anna.kellogg@va.govMore trials in Omaha
PA
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA · Philadelphia, PA 19104-4551Kyle Robinson, MD · Study contact · 215-823-5800 · Kyle.Robinson2@va.govKelly Puchalski, BSN · Study contact · 2158235800 ext. 202333 · Kelly.Puchalski@va.govMore trials in Philadelphia
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA · Pittsburgh, PA 15240James Herman, MD · Study contact · 412-360-3909 · James.Herman@va.govCheryl Dutka, RA · Study contact · 4123602372 · Cheryl.Dutka@va.govMore trials in Pittsburgh
TX
- Michael E. DeBakey VA Medical Center, Houston, TX · Houston, TX 77030-4211Daniel Shin, MD · Study contact · 310-478-3711 · Daniel.Shin@va.govMore trials in Houston