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Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients (PACIFIC-4)

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ClinicalTrials.gov Identifier: NCT03833154
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab versus placebo following SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Durvalumab Other: Placebo Phase 3

Detailed Description:

Patients who complete definitive treatment with SoC SBRT and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab or placebo.

The primary objective of this study is to assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS. Key secondary is to assess the efficacy of Durvalumab monotherapy compared to placebo in terms of OS.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double- Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : October 2, 2023
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Durvalumab Therapy
Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
Drug: Durvalumab
Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
Other Name: MEDI4736

Placebo Comparator: Placebo Therapy
Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Other: Placebo
Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC [ Time Frame: up to 5 years ]
  2. Overall Survival (OS) [ Time Frame: up to 6 years ]
  3. Lung cancer-specific mortality [ Time Frame: up to 6 years ]
  4. Peak Plasma Concentration (Cmax) [ Time Frame: up to 27 months ]
  5. Detection of ADA neutralising antibodies titers [ Time Frame: up to 30 months ]
  6. Health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30 [ Time Frame: up to 6 years ]
  7. Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1 [ Time Frame: at 24 months following randomization ]
  8. Time to progression (TTP) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ]
  9. Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ]
  10. Time from randomisation to second progression (PFS2) as defined by local standard clinical practice [ Time Frame: up to 6 years ]
  11. Trough Concentration (Ctrough) [ Time Frame: up to 27 months ]
  12. Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab compared to placebo after administration of SBRT [ Time Frame: up to 27 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Age ≥18 years
  2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
  3. Completion of SoC SBRT as definitive treatment prior to randomization
  4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
  5. Life expectancy of at least 12 weeks
  6. Body weight >30 kg
  7. Tumor sample required
  8. Adequate organ and marrow function required
  9. Patients with central or peripheral lesions are eligible
  10. Staging studies must be done within 8 weeks before randomization

Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer histology
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥2 from SBRT (Stereotactic Body Radiation Therapy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833154


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: Astrazeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

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Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03833154     History of Changes
Other Study ID Numbers: D9103C00001
2018-002572-41 ( EudraCT Number )
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AstraZeneca:
NSCLC
Double- Blind
PD-L1
MEDI4736
Durvalumab
PFS
OS

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs