ORION

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224711

Enrollment

Registered

2019-06-04

Start date

2019-04-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer NSCLC

Interventions

investigational material(s) Generic name etc : Durvalmab, Olaparib INN of investigational material : durvalmab, olaparib Therapeutic category code : 429 Other antitumor agents Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. - Patients must have tumors that lack activating EGFR mutations and ALK fusions. - (WHO)/(ECOG) performance status of 0 or 1 - No prior chemotherapy or any other systemic therapy for Stage IV NSCLC - Adequate organ and marrow function without blood transfusions in the past 28 days, - At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment - Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. - Creatinine Clearance (CrCl) 51 mL/min or more calculated by Cockcroft-Gault equation or measured by 24-hour urine collection. - Ability to swallow whole oral medications.

Exclusion criteria

Exclusion criteria: - Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. - Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5' diphosphoribose [poly(ADP ribose)] polymerase(PARP) therapy, or immunomediated therapy Active or prior documented autoimmune or inflammatory disorders. - Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. - Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product(IP) - untreated(CNS) metastases and/or carcinomatous meningitis - Active infection. Exclusion criteria to be randomized to maintenance treatment: - Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety exploratory -	—

Countries

Asia except Japan, Europe, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026