A study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer

Phase 1

• Conditions: First line patients with Advanced Non Small-Cell Lung Cancer (NSCLC) with PD-L1 high membrane expression in tumoral tissue and lacking activating epdermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) infusions.; MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001375-21-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

-Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation or ALK rearrangement
- Prior to randomization, patients have PD-L1 high membrane expression in tumoral tissue with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory
- No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC
- World Health Organization (WHO) Performance Status of 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

• Prior chemotherapy or any other systemic therapy for advanced NSCLC
• Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
• Brain metastases or spinal cord compression unless the patient is stable (asymptomatic, no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment
• Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
• Active or prior documented inflammatory bowel disease
• Active infection
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified