Olaparib + Radiotherapy for Small Cell Lung Cancer

No longer recruiting at 11 trial locations
AR
Michael Offin profile photo
Overseen ByMichael Offin
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Platinum agents, Etoposide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using a new medication, Olaparib, alongside radiation therapy for individuals with small cell lung cancer. The goal is to determine if this combination is safe and potentially effective for treating this specific type of lung cancer. Participants with small cell lung cancer that has spread beyond the lungs and who have completed a specific chemotherapy regimen without disease progression might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications that are strong or moderate CYP3A inhibitors or inducers before starting the study drug, Olaparib. There is a washout period (time without taking certain medications) of 2 weeks for strong CYP3A inhibitors and 3 to 5 weeks for moderate CYP3A inducers, depending on the specific medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Olaparib with radiotherapy might be safe for patients. One study found that taking 200mg of Olaparib twice a day was well-tolerated when combined with low-dose radiation, meaning people did not experience unexpected side effects.

Olaparib, a PARP inhibitor, makes cancer cells more sensitive to radiation, potentially enhancing the destruction of cancer cells. Although this treatment is still in early testing stages for small cell lung cancer, it has been shown to be safe in other studies. This suggests that the treatment could be promising and worth further exploration.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for small cell lung cancer, which typically include chemotherapy and radiation, the combination of Olaparib and radiotherapy offers a fresh approach. Olaparib is a PARP inhibitor that works by preventing cancer cells from repairing their DNA, making them more susceptible to damage and destruction. Researchers are particularly excited about this combination because it leverages Olaparib's unique mechanism of action alongside radiotherapy to potentially enhance the treatment's effectiveness. This novel approach could lead to improved outcomes for patients who have limited options with current therapies.

What evidence suggests that Olaparib combined with radiotherapy might be an effective treatment for small cell lung cancer?

Research has shown that adding PARP inhibitors like Olaparib to small cell lung cancer treatment can significantly improve patient outcomes. Specifically, Olaparib increases progression-free survival, allowing patients to live longer without their cancer worsening, and improves the overall response rate, meaning more patients respond well to the treatment when combined with other therapies. Additionally, Olaparib has effectively shrunk tumors in some patients with certain genetic mutations. Radiotherapy, another treatment in this trial, is a well-established method for small cell lung cancer and plays a crucial role in improving survival rates, especially in patients with limited-stage disease. This trial will evaluate the combination of Olaparib with radiotherapy, potentially enhancing treatment effectiveness and offering hope for better management of the condition.678910

Who Is on the Research Team?

AW

Abraham Wu, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.
See 9 more

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.
Women who are currently breastfeeding.
See 23 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with Small Cell Lung CancerExperimental Treatment7 Interventions

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

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Approved in European Union as Lynparza for:
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Approved in United States as Lynparza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

PARP inhibitors for small cell lung cancer and their ...ES-SCLC patients treated with chemotherapy have a low median survival of about 10 months (63,64) with immunotherapy increasing that to about 12 months (65,66).
PARP inhibitors as therapy for small cell lung carcinomaThe cumulative analysis from available data showed that addition of PARPi in current first line therapy for SCLC increases the PFS and ORR significantly, ...
The clinical efficacy of olaparib monotherapy or ...A patient with confirmed PR with a 43% decreases in tumor volume compared with baseline had a mutation in TP53. Conclusions: Targeting the DDR ...
Olaparib monotherapy or combination therapy in lung cancerOlaparib demonstrated a significant improvement in PFS when administered as a monotherapy. However, due to limited data, the efficacy of ...
Phase I/II Investigator-Initiated Study of Olaparib and ...Conclusions: Olaparib/temozolomide may be effective in relapsed SCLC, especially for patients with CNS disease. Ongoing analyses with regard to ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40880183/
Phase I Dose Escalation Trial Combining Olaparib and ...This study defined a MTD and recommended phase II dose of 200mg twice daily olaparib with concurrent low-dose TRT, and the combination ...
Study Details | NCT04728230 | Olaparib and Durvalumab ...Giving olaparib and durvalumab together with carboplatin, etoposide, and/or radiation therapy may help treat patients with ES-SCLC. Detailed Description.
Small Cell Lung Cancer Clinical TrialsThis randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer.
PARP inhibitors combined with radiotherapy: are we ready?The combination of PARP inhibitors and radiotherapy can enhance the sensitivity of cancer cells to radiation, intensify DNA damage, and trigger cell death.
Merck Provides Update on Phase 3 KEYLYNK-006 Trial ...Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With ...
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