New combo therapy targets tough lung cancer
NCT ID NCT04170946
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of combining the drug talazoparib with low-dose chest radiation in people with extensive-stage small cell lung cancer that has not worsened after initial chemotherapy. About 24 participants will receive talazoparib pills daily during radiation to find the best dose with manageable side effects. The goal is to control the disease and delay its return.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Princess Margaret Cancer Center, University Health Network
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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