Recurrent Extensive Stage Small Cell Lung CarcinomaPhase 2NCT03672773
Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Talazoparib and Temozolomide in people with Recurrent Extensive Stage Small Cell Lung Carcinoma and Refractory Extensive Stage Small Cell Lung Carcinoma, run by Jonsson Comprehensive Cancer Center at 6 sites in United States.
Trial summary
This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Extensive Stage Small Cell Lung Carcinoma, Refractory Extensive Stage Small Cell Lung Carcinoma
- What is being tested?
- Talazoparib and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Oct 2018to 1 Oct 2028
- Phase
- Phase 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
- Able to provide informed consent.
- Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.
- Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).
- Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Archival or fresh tissue biopsy available for exploratory analyses.
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.
Show all 19Show fewer
- Able to swallow the study drugs, has no known intolerance to study drugs or excipients, and able to comply with study requirements.
- Female participants of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment.
- Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment. Contraception should be considered for a non-pregnant female partner of childbearing potential.
- Male and female participants must agree not to donate sperm or eggs, respectively, from the first study drug treatment through 105 days and 45 days after the last study drug treatment, respectively.
- Female participants may not be breastfeeding at baseline through 45 days after the last study drug treatment.
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Glomerular filtration rate (by Cockroft-Gault or equivalent estimation) >= 30 mL/min
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for participants with liver metastases
- Serum total bilirubin =< 1.5 X upper limit or normal (ULN) OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 ULN
- International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 or return to baseline) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Best response of progressive disease per RECIST 1.1 to first-line platinum doublet chemotherapy.
- Has received more than 1 line of cytotoxic therapy
- Prior immunotherapy and targeted therapies (including rovalpituzumab tesirine) are allowed.
- Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide.
- Use of antineoplastic therapies within 14 days before study treatment initiation.
Show all 15Show fewer
- Use of any other investigational agent within 14 days before study treatment initiation.
- Received radiation therapy within 14 day before study treatment initiation (single fraction palliative radiotherapy is allowed without a washout).
- Prior thoracic irradiation and prophylactic cranial irradiation are allowed.
- Major surgery within 14 days before study treatment initiation.
- Diagnosis of myelodysplastic syndrome (MDS).
- Gastrointestinal disorder affecting absorption.
- Current or anticipated use of a prohibited P-gp inhibitor or P-gp inducer or BCRP inhibitors.
- History of another cancer within 2 years before study treatment initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early stage breast, prostate, nonmelanomatous skin, thyroid, cervix and endometrial cancer.
- Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Ft. Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
St. Joseph Heritage Healthcare
Fullerton, California, 92835
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Orlando Health, Inc. d/b/a Orlando Health UF Health Center
Orlando, Florida, 32806
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Phase 2 Study of Continuous Talazoparib Plus Intermittent Low-Dose Temozolomide in Patients With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer (TRIO-US L-07)
This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the efficacy of talazoparib in combination with temozolomide as measured by objective response rate (ORR).
SECONDARY OBJECTIVES:
- To evaluate the efficacy of talazoparib plus temozolomide as measured by progression-free survival (PFS), overall survival, duration of response, and time to response.
II. To evaluate the safety, tolerability of talazoparib plus temozolomide. III. To evaluate the pharmacokinetics of talazoparib when given in combination with temozolomide.
IV. To evaluate patient reported outcomes per the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
EXPLORATORY OBJECTIVES:
- To identify potential biomarkers associated with response to study drug treatment.
OUTLINE:
Participants receive temozolomide orally (PO) on days 1-5 and talazoparib PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days and then up to 1 year.
- Conditions
- Recurrent Extensive Stage Small Cell Lung Carcinoma, Refractory Extensive Stage Small Cell Lung Carcinoma
- Being tested
- Talazoparib, Temozolomide
- Keywords
- Small Cell Lung Cancer, PARP Inhibitor
- 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.
TalazoparibDrug
Also called BMN 673, BMN-673
Given PO
TemozolomideDrug
Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (temozolomide, talazoparib) | Experimental | Participants receive temozolomide PO on days 1-5 and talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Talazoparib; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1
Will be provided along with the corresponding exact 2-sided 95% confidence interval calculated using a method based on the F distribution.
Measured: Up to 1 year
Secondary outcomes (6)
Progression-Free Survival (PFS) assessed by RECIST 1.1
Will be summarized for the safety analysis (SA) set. Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.
Measured: From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year
PFS assessed by RECIST 1.1
Will be summarized for the SA set. Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate. Median event times and 2-sided 95% confidence interval for each median will be provided.
Measured: From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year
Overall survival
Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.
Measured: From treatment initiation to death by any cause, assessed up to 1 year
Duration of response (CR or PR) per RECIST 1.1
Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.
Measured: From the first documentation of objective tumor response, assessed up to 1 year
Time to response (CR or PR) per RECIST 1.1
Will be summarized using the Kaplan-Meier method and displayed graphically when appropriate.
Measured: From treatment initiation to the first documentation of objective tumor response, assessed up to 1 year
Pharmacokinetics of talazoparib - steady state trough plasma concentrations
To evaluate the pharmacokinetics (steady state trough plasma concentrations) of talazoparib when given in combination with temozolomide
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start31 Oct 2018
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Extensive Stage Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Research in Oncology, Pfizer
- Responsible party
- Sponsor
- Investigators
- Jonathan Goldman, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672773
- Sponsor's protocol ID
- 18-001387
- Other IDs
- NCI-2018-01409, TRIO-US L-07
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2018
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Continuous Talazoparib Plus Intermittent Low-Dose Temozolomide in Patients With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer (TRIO-US L-07)
- ClinicalTrials.gov ID
- NCT03672773
- Acronym / sponsor ID
- 18-001387
- Conditions
- Recurrent Extensive Stage Small Cell Lung Carcinoma, Refractory Extensive Stage Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Cancer, PARP Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Translational Research in Oncology, Pfizer
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 14 Sep 2018 (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.
This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the efficacy of talazoparib in combination with temozolomide as measured by objective response rate (ORR).
SECONDARY OBJECTIVES:
- To evaluate the efficacy of talazoparib plus temozolomide as measured by progression-free survival (PFS), overall survival, duration of response, and time to response.
II. To evaluate the safety, tolerability of talazoparib plus temozolomide. III. To evaluate the pharmacokinetics of talazoparib when given in combination with temozolomide.
IV. To evaluate patient reported outcomes per the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
EXPLORATORY OBJECTIVES:
- To identify potential biomarkers associated with response to study drug treatment.
OUTLINE:
Participants receive temozolomide orally (PO) on days 1-5 and talazoparib PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days and then up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (temozolomide, talazoparib) | Experimental | Drug: Talazoparib, Drug: TemozolomideParticipants receive temozolomide PO on days 1-5 and talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to provide informed consent.
- Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.
- Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).
- Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Archival or fresh tissue biopsy available for exploratory analyses.
Key exclusion criteria (15 listed)
- Has not recovered (recovery is defined as Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 or return to baseline) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Best response of progressive disease per RECIST 1.1 to first-line platinum doublet chemotherapy.
- Has received more than 1 line of cytotoxic therapy
- Prior treatment with a PARP inhibitor (not including iniparib) or temozolomide.
- Use of antineoplastic therapies within 14 days before study treatment initiation.
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 |
|---|---|---|
| TalazoparibAlso: BMN 673, BMN-673Given PO | Drug | Treatment (temozolomide, talazoparib) |
| TemozolomideAlso: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831Given PO | Drug | Treatment (temozolomide, talazoparib) |
Primary outcome
Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1
Time frame: Up to 1 year
Will be provided along with the corresponding exact 2-sided 95% confidence interval calculated using a method based on the F distribution.
6 secondary outcomes
Progression-Free Survival (PFS) assessed by RECIST 1.1
Time frame: From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year
PFS assessed by RECIST 1.1
Time frame: From treatment initiation to time of first documentation of objective tumor progression or death on study due to any cause, whichever occurs first, assessed up to 1 year
Overall survival
Time frame: From treatment initiation to death by any cause, assessed up to 1 year
Duration of response (CR or PR) per RECIST 1.1
Time frame: From the first documentation of objective tumor response, assessed up to 1 year
Time to response (CR or PR) per RECIST 1.1
Time frame: From treatment initiation to the first documentation of objective tumor response, assessed up to 1 year
Pharmacokinetics of talazoparib - steady state trough plasma concentrations
Time frame: Up to 1 year
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 20 Oct 2026.
Related trials for Recurrent Extensive Stage Small Cell Lung Carcinoma
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
Active, not recruitingPhase 2
Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer
Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma
RecruitingPhase 1
Iadademstat + SBRT With Atezo in ES-SCLC
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
RecruitingPhase 1/2
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer (SCLC), Relapsed/Refractory SCLC
Active, not recruitingPhase 2
Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
Extensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma
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. This study is not recruiting at the moment.
Jonathan Goldman, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talazoparib and Temozolomide in people with Recurrent Extensive Stage Small Cell Lung Carcinoma and Refractory Extensive Stage Small Cell Lung Carcinoma, run by Jonsson Comprehensive Cancer Center at 6 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 19 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1 (time frame: Up to 1 year). 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 20 Oct 2026.