Study on Olaparib and Durvalumab with Chemotherapy and Radiation for Treating Extensive-Stage Small Cell Lung Cancer (PRIO Trial)
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT04728230
This clinical trial is exploring the safety and effectiveness of combining the drugs olaparib and durvalumab with chemotherapy and radiation therapy to treat patients with extensive-stage small cell lung cancer (ES-SCLC) who have not yet received treatment.
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Program Overview
This study is investigating how well the combination of olaparib and durvalumab works with chemotherapy drugs carboplatin and etoposide, and possibly radiation therapy, in treating patients with extensive-stage small cell lung cancer (ES-SCLC). Olaparib is a drug that stops cancer cells from repairing themselves, while durvalumab helps the immune system attack cancer cells. Chemotherapy drugs work by killing cancer cells or stopping them from growing. Radiation therapy uses high-energy rays to kill cancer cells. The goal is to see if this combination can effectively treat ES-SCLC.
Description
The study is divided into several phases:
Chemo-Immunotherapy Phase:
- Patients receive durvalumab, carboplatin, and etoposide through an IV. This treatment is repeated every 21 days for up to 4 cycles, as long as the cancer does not progress or cause severe side effects.
- Patients who respond well or have stable disease after 4 cycles may proceed to the next phase.
Induction Phase (Weeks 13-14):
- Patients take olaparib orally twice a day for 11 days, unless the cancer progresses or side effects become unacceptable.
Immunoradiation Phase (Weeks 15-18):
- Patients receive durvalumab through an IV and undergo radiation therapy on specific days, unless the cancer progresses or side effects become unacceptable.
Maintenance Phase (Weeks 19 and Beyond):
- Patients without cancer progression continue to receive durvalumab and olaparib. This cycle repeats every 28 days, as long as the cancer does not progress or cause severe side effects.
Single-Agent Maintenance:
- Patients receive durvalumab through an IV every 28 days, as long as the cancer does not progress or cause severe side effects.
After completing the study treatment, patients are monitored for 30 days, then every 3 months.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent to participate in the study and optional genetic and biomarker research.
- Have at least one tumor that can be measured by a CT scan.
- Patients with treated brain metastases that are stable and require minimal medication.
- Diagnosed with extensive-stage small cell lung cancer (ES-SCLC).
- No prior systemic therapy for ES-SCLC.
- Good overall health with an ECOG performance status of 0-1.
- Body weight over 30 kg.
- Meet specific blood test requirements for hemoglobin, neutrophil, and platelet counts.
- Normal liver and kidney function as indicated by blood tests.
- Women must not be pregnant and must use effective birth control during and after the study.
- Men must use condoms during and after the study.
- Willing to comply with study procedures and follow-up visits.
Exclusion Criteria
- Have a different type of cancer than small cell lung cancer.
- Have received prior treatment for ES-SCLC.
- Have untreated brain metastases.
- Have had major surgery within 28 days before starting the study.
- Have another active cancer unless treated and in remission for at least 3 years.
- Have uncontrolled heart conditions or other serious medical issues.
- Have an autoimmune disease requiring treatment in the past 2 years.
- Have active infections or are immunocompromised.
- Have received a live vaccine within 30 days before the study.
- Are pregnant or breastfeeding.
- Have allergies to study drugs.
- Have ongoing severe side effects from previous cancer treatments.
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