Olaparib + Radiotherapy for Small Cell Lung Cancer

Recruiting at 11 trial locations

Overseen By Michael Offin

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Platinum agents, Etoposide

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Brain metastases, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.

Research Team

Abraham Wu, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with small cell lung cancer who've finished at least 4 cycles of specific chemotherapy without disease progression. They must be postmenopausal or not able to bear children, have a good performance status, and recovered from previous treatments. No recent investigational drugs, systemic chemo, or radiotherapy are allowed.

Inclusion Criteria

My lung disease can be targeted with radiation according to my doctor.

My blood tests, liver, and kidney functions are within normal ranges.

I am postmenopausal or cannot become pregnant.

Exclusion Criteria

I have had treatment for spinal cord compression and have been stable for 28 days.

I have brain metastases that have not been treated.

I have inflammation in my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Olaparib combined with low dose thoracic radiotherapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Olaparib
• Radiotherapy

Trial Overview The study tests different doses of Olaparib pills (ranging from 50 mg to 300 mg) combined with low dose radiotherapy on patients with small cell lung cancer. The goal is to determine the safety and effectiveness of this combination treatment.

Participant Groups

Group I: Participants with Small Cell Lung Cancer Experimental Treatment 7 Interventions

Olaparib is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+