Relapsed Small Cell Lung CancerPhase 1/2Relapsed SCLCNCT06681220
Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
A Phase 1/2 study testing Stenoparib/Temozolomide and Lurbinectedin in people with Relapsed Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by VA Office of Research and Development at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- What is being tested?
- Stenoparib/Temozolomide and Lurbinectedin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Feb 2026to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Nithya Ramnath,, MD, 734-845-5800, nithya.ramnath@va.gov
Kelsey Bollin, BSN, (734) 8453966, Kelsey.Bollin@va.gov
- Not yet recruiting
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Larry Feldman, MD, 312-569-5385, lawrence.feldman@va.gov
Alicia Hulbert, MD, 3124138878, alicia.hulbert@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Daniel Shin, MD, 310-478-3711, Daniel.Shin@va.gov
- Recruiting
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
Shadia Jalal, MD, 317-274-5500, Shadia.Jalal@va.gov
Aleksandra Radovanovich, RN, (317) 988-3338, aleksandra.radovanovich@va.gov
- Not yet recruiting
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, 40206-1433
Fred Hendler, MD, 502-287-4000, Fred.Hendler@va.gov
Denise Zellars, MHA, 5022875222, Denise.Zellars@va.gov
- Not yet recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Mark Klein, MD, 612-467-4682, Mark.Klein2@va.gov
Jasmeen Chauhan, BA, 6124674682, Jasmeen.Chauhan@va.gov
- Not yet recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Apar Ganti, MD, 402-346-8800, aparkishor.ganti@va.gov
Anna Kellogg, MS, 4029954143, anna.kellogg@va.gov
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Millie Das, MD, 650-493-5000 ext. 66133, Millie.Das@va.gov
Niko Del Mar, RA, 6504935000 ext. 65610, niko.delmar@va.gov
- Recruiting
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Kyle Robinson, MD, 215-823-5800, Kyle.Robinson2@va.gov
Kelly Puchalski, BSN, 2158235800 ext. 202333, Kelly.Puchalski@va.gov
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
James Herman, MD, 412-360-3909, James.Herman@va.gov
Cheryl Dutka, RA, 4123602372, Cheryl.Dutka@va.gov
- Recruiting
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
Jimmy Ruiz, MD, 704-638-9000, Jimmy.Ruiz@va.gov
Travis Gallimore, RC, (704) 6389000 ext. 14419, Travis.Gallimore@va.gov
About this study
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.
Read the detailed 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. 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.
- Being tested
- Stenoparib/Temozolomide, Lurbinectedin
- Keywords
- Phase 2, Small Cell Lung Cancer, Biomarker
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenoparib/TemozolomideCombination product
Also called Stenoparib/TEMODAR
Stenoparib at the recommended phase 2 dose +Temozolomide 40mg/day daily will be given in combination x21 days each cycle
LurbinectedinDrug
Also called Zepzelca
Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion x 21 days each cycle
Stenoparib/TemozolomideCombination product
Also called Stenoparib/TEMODAR
Patients will be assigned to one of three doses of Stenoparib (200mg po qd, 200mg po BID, and 200mg in am and 400mg in pm). The initial starting dose will be the 200 mg po QD orally daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Study Drug Combination | Experimental | Biomarker positive patients will be randomized 2:1 to study drug (Stenoparib at the recommended phase 2 dose +TMZ 40mg/day daily) or (Standard of Care) Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity Receives: Combination Product: Stenoparib/Temozolomide |
| Standard of Care | Active comparator | Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity Receives: Drug: Lurbinectedin |
| Biomarker Negative Standard of Care | Active comparator | Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity Receives: Drug: Lurbinectedin |
| Safety lead-in | Experimental | Biomarker positive patients will be assigned to one of three doses of Stenoparib (200mg po qd, 200mg po BID, and 200mg in am and 400mg in pm). The initial starting dose will be the 200 mg po QD orally daily for 21 days. Receives: Combination Product: Stenoparib/Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
According to response evaluation criteria in solid tumors RECIST 1.1(imaging criteria or progression or patient death).
Measured: Through study completion up to 2 years.
Recommended Phase 2 dose
Defined as the recommended dose of Stenoparib for phase 2
Measured: Through end of cycle 1 (21 days)
Secondary outcomes (5)
Disease control rate (DCR)
Defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) per RECIST 1.1.
Measured: Through study completion up to 2 years.
Overall Survival (OS)
Will be measured from Day 1 of treatment until death from any cause.
Measured: Through study completion up to 2 years.
Overall response rate (ORR)
Defined as complete response (CR) + partial response (PR) per RECIST 1.1 criteria.
Measured: Through study completion up to 2 years.
Treatment Toxicities
As defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Through study completion up to 2 years.
Progression Free Survival (PFS)
Compare PFS between biomarker positive and biomarker negative patient receiving Lurbinectedin.
Measured: Through study completion up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start23 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectin for 21-day cycles.
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shadia Jalal, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681220
- Sponsor's protocol ID
- SPLP-002-24S
- Other IDs
- 14094144/CX002801-01A1
- Acronym
- Relapsed SCLC
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC
- ClinicalTrials.gov ID
- NCT06681220
- Acronym / sponsor ID
- Relapsed SCLC / SPLP-002-24S
- Keywords
- Phase 2, Small Cell Lung Cancer, Biomarker
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectin for 21-day cycles.
| Arm | Type | Receives |
|---|---|---|
| Study Drug Combination | Experimental | Combination Product: Stenoparib/TemozolomideBiomarker positive patients will be randomized 2:1 to study drug (Stenoparib at the recommended phase 2 dose +TMZ 40mg/day daily) or (Standard of Care) Lurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity |
| Standard of Care | Active comparator | Drug: LurbinectedinLurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity |
| Biomarker Negative Standard of Care | Active comparator | Drug: LurbinectedinLurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion each cycle x21 days until disease progression or intolerable toxicity |
| Safety lead-in | Experimental | Combination Product: Stenoparib/TemozolomideBiomarker positive patients will be assigned to one of three doses of Stenoparib (200mg po qd, 200mg po BID, and 200mg in am and 400mg in pm). The initial starting dose will be the 200 mg po QD orally daily for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stenoparib/TemozolomideAlso: Stenoparib/TEMODARStenoparib at the recommended phase 2 dose +Temozolomide 40mg/day daily will be given in combination x21 days each cycle | Combination product | Study Drug Combination |
| LurbinectedinAlso: ZepzelcaLurbinectedin 3.2mg/m2 one-hour intravenous (IV) infusion x 21 days each cycle | Drug | Biomarker Negative Standard of Care, Standard of Care |
| Stenoparib/TemozolomideAlso: Stenoparib/TEMODARPatients will be assigned to one of three doses of Stenoparib (200mg po qd, 200mg po BID, and 200mg in am and 400mg in pm). The initial starting dose will be the 200 mg po QD orally daily for 21 days. | Combination product | Safety lead-in |
Primary outcome
Progression Free Survival (PFS)
Time frame: Through study completion up to 2 years.
According to response evaluation criteria in solid tumors RECIST 1.1(imaging criteria or progression or patient death).
Recommended Phase 2 dose
Time frame: Through end of cycle 1 (21 days)
Defined as the recommended dose of Stenoparib for phase 2
5 secondary outcomes
Disease control rate (DCR)
Time frame: Through study completion up to 2 years.
Overall Survival (OS)
Time frame: Through study completion up to 2 years.
Overall response rate (ORR)
Time frame: Through study completion up to 2 years.
Treatment Toxicities
Time frame: Through study completion up to 2 years.
Progression Free Survival (PFS)
Time frame: Through study completion up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shadia Jalal, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stenoparib/Temozolomide and Lurbinectedin in people with Relapsed Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer, run by VA Office of Research and Development at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shadia Jalal, MD ((317) 274-5500, Shadia.Jalal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Through study completion up to 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.