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Clinical Trials in India / NCT03775486
Active, not recruiting Phase 2

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

NCT03775486 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2018-12-21
Last updated
2026-09-11

Condition(s) studied

Non-small Cell Lung Cancer NSCLC

Investigational drug(s) / intervention(s)

DurvalumabPlacebo for OlaparibOlaparibNab-paclitaxel+carboplatinGemcitabine+carboplatinPemetrexed+carboplatinGemcitabine+cisplatinPemetrexed+cisplatin

Durvalumab: Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.

Placebo for Olaparib: Matching tablet

Olaparib: 150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required

Nab-paclitaxel+carboplatin: Standard of Care chemotherapy (squamous and non-squamous patients)

Gemcitabine+carboplatin: Standard of Care chemotherapy (squamous patients only)

Pemetrexed+carboplatin: Standard of Care chemotherapy (non-squamous patients only)

Gemcitabine+cisplatin: Standard of Care chemotherapy (squamous patients only)

Pemetrexed+cisplatin: Standard of Care chemotherapy (non-squamous patients only)

Study summary

This is a randomized, double-blind, multi-center, global Phase II 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 (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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 calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection. * Ability to swallow whole oral medications. * All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (\<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken \<3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit. 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.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Research Site Bonita Springs Florida
Research Site St. Petersburg Florida
Research Site Tallahassee Florida
Research Site West Palm Beach Florida
Research Site Kansas City Missouri
Research Site Bethlehem Pennsylvania
Research Site Chattanooga Tennessee
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site Aalst Belgium
Research Site Leuven Belgium
Research Site Roeselare Belgium
Research Site Budapest Hungary
Research Site Budapest Hungary
Research Site Debrecen Hungary
Research Site Deszk Hungary
Research Site Farkasgyepü Hungary
Research Site Törökbálint Hungary
Research Site Ahmedabad India
Research Site Ahmedabad India
Research Site Jamnagar India
Research Site Kochi India
Research Site Mysuru India
Research Site Nashik India
Research Site Nashik India
Research Site Pune India
Research Site Thiruvananthapuram India
Research Site Chūōku Japan
Research Site Kanazawa Japan
Research Site Kurume-shi, Japan
Research Site Matsuyama Japan
Research Site Nagoya Japan
Research Site Sendai Japan
Research Site Sunto-gun Japan
Research Site Ube-shi Japan
Research Site Chihuahua City Mexico
Research Site Culiacán Mexico
Research Site San Luis Potosí City Mexico
Research Site Blaricum Netherlands
Research Site Harderwijk Netherlands

+ 28 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Lynparza (olaparib) drug profile →

More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03775486 on ClinicalTrials.gov ↗ ← All trials in India