A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients (PACIFIC-5)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Durvalumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03706690

D933YC00001

2018-002294-22 (EudraCT Number)

Details and patient eligibility

About

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.

Full description

Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.

Enrollment: 407 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years
2. Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
3. Receipt of concurrent or sequential chemoradiation therapy,
4. No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
5. World Health Organization (WHO) PS of 0 or 1;
6. No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
7. Adequate organ and marrow function required
8. Life expectancy of at least 12 weeks
9. Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
10. Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample <=3 months old is preferred, but an archived sample <=6 months old is acceptable) in a quantity sufficient to allow for analysis.

Exclusion criteria

1. History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
4. Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies).
5. Mixed small cell and NSCLC histology, sarcomatoid variant
6. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
7. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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407 participants in 2 patient groups, including a placebo group

Durvalumab Therapy

Experimental group

Description:

Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/deterioration or confirmed radiological progression)

Treatment:

Drug: Durvalumab

Placebo Therapy

Placebo Comparator group

Description:

Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)

Treatment:

Other: Placebo