Recruiting
Phase 1

Talazoparib & Thoracic RT

Sponsor:

University Health Network, Toronto

Code:

NCT04170946

Conditions

Lung Cancer

Small-Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Talazoparib in Combination with Low Dose Radiotherapy (RT)

Study Details

Brief 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.

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.

Conditions

Lung Cancer

Small-Cell Lung Cancer

Study ID

NCT04170946

Start date

Oct 5, 2020

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Talazoparib in Combination with Low Dose 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.

Interventions

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.

Primary outcome measure

  • Safety of Talazoparib in Combination with Low Dose Thoracic Radiotherapy [ Time Frame: Up to 3 years upon enrollment ]
  • Maximum Tolerated Dose (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiotherapy [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Benjamin Lok, MD

416-946-4501Benjamin.Lok@rmp.uhn.ca

Locations

Princess Margaret Cancer Center, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Benjamin Lok, MD

416-946-4501Benjamin.Lok@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Talazoparib
  • Thoracic Radiotherapy
  • Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.