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Trial record 1 of 1 for:    NCT03833154
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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 : Recruiting
First Posted : February 6, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date October 2, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03833154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • 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 ]
  • Overall Survival (OS) [ Time Frame: up to 6 years ]
  • Lung cancer-specific mortality [ Time Frame: up to 6 years ]
  • Peak Plasma Concentration (Cmax) [ Time Frame: up to 27 months ]
  • Detection of ADA neutralising antibodies titers [ Time Frame: up to 30 months ]
  • 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 ]
  • 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 ]
  • Time to progression (TTP) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ]
  • Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 [ Time Frame: up to 5 years ]
  • Time from randomisation to second progression (PFS2) as defined by local standard clinical practice [ Time Frame: up to 6 years ]
  • Trough Concentration (Ctrough) [ Time Frame: up to 27 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double- Blind
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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
  • Other: Placebo
    Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Durvalumab
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
630
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date October 2, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium,   Canada,   China,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03833154
Other Study ID Numbers  ICMJE D9103C00001
2018-002572-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP