~8 spots leftby Sep 2027

Talazoparib + Radiotherapy for Small Cell Lung Cancer

BL
Overseen byBenjamin Lok, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: Platinum agents, Etoposide
Must not be taking: P-gp inhibitors, BCRP inhibitors
Disqualifiers: Brain metastases, Myelodysplastic syndrome, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs like strong P-gp inhibitors or other P-gp and BCRP inhibitors while participating. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Talazoparib in combination with radiotherapy for treating small cell lung cancer?

Research shows that Talazoparib, when combined with other drugs, can work well against small cell lung cancer cells in the lab. This suggests it might be effective when used with radiotherapy for this type of cancer.12345

What makes the drug Talazoparib unique for treating small cell lung cancer?

Talazoparib is unique because it is a PARP inhibitor that enhances the effectiveness of radiotherapy by increasing DNA damage in cancer cells, making them more sensitive to radiation. This combination approach is novel for small cell lung cancer, which is an aggressive type of cancer with limited treatment options.12678

Research Team

BL

Benjamin Lok, MD

Principal Investigator

Princess Margaret Cancer Center

Eligibility Criteria

This trial is for adults with extensive-stage small cell lung cancer who finished 4-6 cycles of specific chemotherapy without disease progression. They must be able to swallow pills, have good organ function, and not be pregnant or breastfeeding. Excluded are those with untreated brain metastases, prior PARP inhibitor treatment, recent other cancer treatments, serious medical conditions or infections.

Inclusion Criteria

My organs and bone marrow are working well.
I have completed 4-6 cycles of chemotherapy with a platinum agent and etoposide.
I am postmenopausal or not able to bear children, confirmed by a recent negative pregnancy test.
See 4 more

Exclusion Criteria

I have had a bone marrow or cord blood transplant in the past.
I am not taking any drugs that affect drug transport in my body.
I am not taking strong P-gp inhibitors.
See 14 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talazoparib starting on day 1 and low dose thoracic radiotherapy starting on day 6-9 for 10 fractions over 2 weeks

3-4 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Follow-up at 3 weeks, then every 3 months

Treatment Details

Interventions

  • Low Dose Radiotherapy (RT) (Radiation)
  • Talazoparib (PARP Inhibitor)
Trial OverviewThe study tests the safety of combining talazoparib (a pill) with low dose thoracic radiotherapy in escalating doses to find the highest dose patients can tolerate without severe side effects. Up to 24 patients will start at a lower dose and may increase if it's safe.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Talazoparib in Combination with Low Dose RTExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+
Dr. Brad Wouters profile image

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith profile image

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In the EMBRACA trial involving 431 patients with gBRCA1/2-mutated advanced breast cancer, talazoparib did not significantly improve overall survival compared to chemotherapy, with a hazard ratio of 0.848 (P = 0.17).
However, talazoparib showed a significant advantage in improving patient-reported outcomes and delaying deterioration in quality of life and breast symptoms, indicating its potential benefits beyond survival rates.
Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial.Litton, JK., Hurvitz, SA., Mina, LA., et al.[2023]
Talazoparib is an oral PARP inhibitor recently approved in the USA for treating adults with specific types of breast cancer, particularly those with BRCA mutations, highlighting its targeted efficacy in a defined patient population.
The drug is also being explored for use in other cancers, including metastatic castration-resistant prostate cancer and early triple negative breast cancer, indicating its potential versatility in cancer treatment.
Talazoparib: First Global Approval.Hoy, SM.[2020]
The combination of atezolizumab, a PD-L1 inhibitor, with platinum-based chemotherapy significantly improves overall survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone.
This research suggests that this combination therapy could become a new first-line treatment option for patients suffering from this aggressive form of lung cancer.
Study: Atezolizumab Improves Survival in SCLC.[2019]

References

Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. [2023]
Talazoparib: First Global Approval. [2020]
Study: Atezolizumab Improves Survival in SCLC. [2019]
BET-Inhibitor I-BET762 and PARP-Inhibitor Talazoparib Synergy in Small Cell Lung Cancer Cells. [2021]
Comparison between talazoparib and conventional chemotherapy in the treatment of HER2-positive breast cancer patients: A retrospective study. [2022]
Talazoparib Is a Potent Radiosensitizer in Small Cell Lung Cancer Cell Lines and Xenografts. [2020]
Phase I, Dose-Escalation, Two-Part Trial of the PARP Inhibitor Talazoparib in Patients with Advanced Germline BRCA1/2 Mutations and Selected Sporadic Cancers. [2022]
Talazoparib Bests Chemo for Breast Cancer. [2019]