Durvalumab + Olaparib for Non-Small Cell Lung Cancer (ORION Trial)

Recruiting in Palo Alto (17 mi)

+64 other locations

Overseen ByMyung-Ju Ahn, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a combination of two drugs, Durvalumab and Olaparib, against using just Durvalumab alone. It targets adults with advanced lung cancer that cannot be treated with surgery or radiation and lacks certain genetic mutations. Durvalumab helps the immune system attack cancer, while Olaparib prevents cancer cells from repairing themselves. Durvalumab is a standard drug used after initial treatment in patients with advanced non-small cell lung cancer.

Eligibility Criteria

This trial is for Stage IV non-small cell lung cancer patients without certain genetic mutations, who've had no prior systemic therapy and responded to initial chemo with Durvalumab. They must be able to perform daily activities with little or no assistance, swallow pills, and have proper kidney function and organ health.

Inclusion Criteria

I have not received any treatment for stage IV non-small cell lung cancer.

I can swallow pills whole.

I am fully active or restricted in physically strenuous activity but can do light work.

I have at least one tumor that can be measured and has not been treated with radiation.

My cancer does not have EGFR mutations or ALK fusions.

My kidney function, measured by creatinine clearance, is good.

My lung cancer is at stage IV and cannot be cured with surgery or radiation.

Exclusion Criteria

My lung cancer is a mix of small-cell and sarcomatoid types.

I am not currently on any cancer treatments like chemotherapy or hormone therapy.

I haven't taken immunosuppressive drugs in the last 14 days.

I have brain metastases or carcinomatous meningitis that hasn't been treated.

I currently have an infection.

I have or had an autoimmune or inflammatory disorder.

I couldn't complete 4 cycles of platinum-based chemotherapy or stopped taking Durvalumab during the first treatment.

Participant Groups

The ORION study tests if adding Olaparib to Durvalumab maintenance therapy is more effective than Durvalumab alone after initial chemo in advanced lung cancer patients. It's a global Phase II trial where participants are randomly assigned treatment options in a blinded manner.

2Treatment groups

Experimental Treatment

Group I: Durvalumab/Olaparib Combination TherapyExperimental Treatment7 Interventions

Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)

Group II: Durvalumab MonotherapyExperimental Treatment7 Interventions

Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)