Lung CancerPhase 1TalazoparibNCT04170946
Talazoparib and Thoracic RT for ES-SCLC
A Phase 1 study testing Talazoparib in Combination with Low Dose Radiotherapy (RT) in people with Lung Cancer and Small-Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small-Cell Lung Cancer
- What is being tested?
- Talazoparib in Combination with Low Dose Radiotherapy (RT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2020to Sep 2027
- Phase
- Phase 1
- 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
- Histological documented diagnosis of SCLC confirmed by a UHN pathologist.
- Documented extensive disease
- Completion of induction chemotherapy, 4-6 cycles of a platinum agent and etoposide.
- No disease progression (i.e.SD or better response by RECIST 1.1) at the completion of chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnosfsky Performance Score (KPS) ≥50; see Appendix B).
- Adequate organ and marrow function,
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
Who cannot join
- Untreated brain metastases.
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patients receiving any systemic chemotherapy, radiotherapy or immunotherapy (except for standard of care treatments or palliative reasons) within 3 weeks prior to study treatment.
- Exposure to an investigational product within 30 days or 5 half-lives (whichever is longer) prior to start of the current study drug.
- Any previous treatment with PARP inhibitor, including talazoparib.
- Concomitant use of strong P-gp inhibitors
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- Concomitant use of other known P-gp inhibitors, P-gp inducers, or BCRP inhibitors
- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome/acute leukaemia or with features suggestive thereof.
- Major surgery within 2 weeks of study treatment initiation and patients must have recovered from any effects of any major surgery.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active/uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Immunocompromised patients,
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Whole blood transfusions in the last 120 days prior to entry to the study
- Other malignancy within the last 5 years
- Patients with spinal cord compression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, M5G 2M9
Benjamin Lok, MD, 416-946-4501 ext. 5819, Benjamin.Lok@rmp.uhn.ca
About this study
Official title: A Phase I Study of Talazoparib and Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy.
Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.
Read the detailed description
This is a phase I, dose escalating study evaluating the safety of combination talazoparib and low dose consolidative thoracic radiotherapy for extensive-stage small cell lung cancer patients with at least stable disease after standard of care 4 - 6 cycles of chemotherapy (a platinum agent and etoposide). This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Secondary objectives will be to examine clinical outcomes, including locoregional recurrence within the radiation field, progression-free survival, overall survival and acute/chronic toxicities up to 1 year.
Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT. Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year.
- Conditions
- Lung Cancer, Small-Cell Lung Cancer
- Being tested
- Talazoparib in Combination with Low Dose Radiotherapy (RT)
- Keywords
- Talazoparib, Thoracic Radiotherapy, Chemotherapy
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talazoparib in Combination with Low Dose Radiotherapy (RT)Other
Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT.
| Study group | Role | What they receive |
|---|---|---|
| Talazoparib in Combination with Low Dose RT | Experimental | Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT (until day 20-23). Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Talazoparib dose levels will start at 0.5mg daily and increase to 1mg if dose limiting toxicites are not observed. Toxicities include renal impairment and other treatment related toxicities Grade ≥3. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year. Receives: Other: Talazoparib in Combination with Low Dose Radiotherapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy
Safety will be measured by assessing all adverse events as determined by the investigator using CTCAE v.5.0.
Measured: Up to 3 years upon enrollment
Maximum Tolerated Dose (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiotherapy
MTD will be defined as the maximum dose by a standard 3+3 design
Measured: Up to 1 year
Secondary outcomes (5)
Loco-regional Recurrence
Loco-regional recurrence will be assessed by using RECIST v1.1 criteria
Measured: 6 months and 1 year
Progression-Free Survival (PFS)
PFS will be defined as the time of start of radiotherapy to first local/loco-regional or distance recurrence event, or death.
Measured: 6 months and 1 year
Overall Survival (OS)
OS will be defined as the time from the start of radiotherapy to death from any cause.
Measured: 6 months and 1 year
Acute Toxicities
Acute toxicities will be assessed by physician-graded CTCAE.
Measured: Up to 1 year
Chronic Toxicities
Chronic toxicities will be assessed by physician-graded CTCAE.
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 posted20 Nov 2019
- Study start5 Oct 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation based on the maximum tolerated dose from each previous cohort within the study.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Benjamin Lok, MD, Principal investigator, Princess Margaret Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170946
- Sponsor's protocol ID
- 19-5621
- Acronym
- Talazoparib
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Talazoparib and Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04170946
- Acronym / sponsor ID
- Talazoparib / 19-5621
- Conditions
- Lung Cancer, Small-Cell Lung Cancer
- Keywords
- Talazoparib, Thoracic Radiotherapy, Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Nov 2019 (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 is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy.
Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.
Detailed description
This is a phase I, dose escalating study evaluating the safety of combination talazoparib and low dose consolidative thoracic radiotherapy for extensive-stage small cell lung cancer patients with at least stable disease after standard of care 4 - 6 cycles of chemotherapy (a platinum agent and etoposide). This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Secondary objectives will be to examine clinical outcomes, including locoregional recurrence within the radiation field, progression-free survival, overall survival and acute/chronic toxicities up to 1 year.
Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT. Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation based on the maximum tolerated dose from each previous cohort within the study.
| Arm | Type | Receives |
|---|---|---|
| Talazoparib in Combination with Low Dose RT | Experimental | Other: Talazoparib in Combination with Low Dose Radiotherapy (RT)Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT (until day 20-23). Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Talazoparib dose levels will start at 0.5mg daily and increase to 1mg if dose limiting toxicites are not observed. Toxicities include renal impairment and other treatment related toxicities Grade ≥3. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological documented diagnosis of SCLC confirmed by a UHN pathologist.
- Documented extensive disease
- Completion of induction chemotherapy, 4-6 cycles of a platinum agent and etoposide.
- No disease progression (i.e.SD or better response by RECIST 1.1) at the completion of chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnosfsky Performance Score (KPS) ≥50; see Appendix B).
Key exclusion criteria (17 listed)
- Untreated brain metastases.
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patients receiving any systemic chemotherapy, radiotherapy or immunotherapy (except for standard of care treatments or palliative reasons) within 3 weeks prior to study treatment.
- Exposure to an investigational product within 30 days or 5 half-lives (whichever is longer) prior to start of the current study drug.
- Any previous treatment with PARP inhibitor, including talazoparib.
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 |
|---|---|---|
| Talazoparib in Combination with Low Dose Radiotherapy (RT)Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT. | Other | Talazoparib in Combination with Low Dose RT |
Primary outcome
Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy
Time frame: Up to 3 years upon enrollment
Safety will be measured by assessing all adverse events as determined by the investigator using CTCAE v.5.0.
Maximum Tolerated Dose (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiotherapy
Time frame: Up to 1 year
MTD will be defined as the maximum dose by a standard 3+3 design
5 secondary outcomes
Loco-regional Recurrence
Time frame: 6 months and 1 year
Progression-Free Survival (PFS)
Time frame: 6 months and 1 year
Overall Survival (OS)
Time frame: 6 months and 1 year
Acute Toxicities
Time frame: Up to 1 year
Chronic Toxicities
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 5 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.
Benjamin Lok, MD principal investigator
Princess Margaret Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talazoparib in Combination with Low Dose Radiotherapy (RT) in people with Lung Cancer and Small-Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 17 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 5 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 1 site in Canada. 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 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.
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 Benjamin Lok, MD (416-946-4501 ext. 5819, Benjamin.Lok@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy (time frame: Up to 3 years upon enrollment). 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 5 Mar 2026.