Pacific 4: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with 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)

  • STATUS
    Recruiting
  • sponsor
    AstraZeneca
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Updated on 26 August 2022
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EGFR
durvalumab
osimertinib

Summary

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

Description

Patients who are to receive SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to Durvalumab or placebo.
The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).
In addition, a study cohort with a sufficient number of patients harboring an EGFR mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4years-PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

Details
Condition Carcinoma, Non-Small Cell Lung Cancer
Clinical Study IdentifierTX306104
SponsorAstraZeneca
Last Modified on26 August 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Main Cohort Key Inclusion Criteria
Age ≥18 years
Planned SoC SBRT as definitive treatment
World Health Organization (WHO)/ECOG PS of 0, 1, or 2
WHO/ECOG PS of 0, 1 or 2
Patients with central or peripheral lesions are eligible
Life expectancy of at least 12 weeks
Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
Staging studies must be done during screening (PET-CT within 10 weeks)
Body weight >30 kg
Submission of tumor tissue sample if available
Submission of available tumor tissue sample
Adequate organ and marrow function required
Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
Adequate bone marrow reserve or organ function required
Female patients should be using highly effective contraceptive measures
Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation
Osimertinib Cohort Key Inclusion Criteria
Age ≥18 years
Planned SoC SBRT as definitive treatment
Patients with central or peripheral lesions are eligible
Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
Staging studies must be done during screening (PET-CT within 10 weeks)

Exclusion Criteria

Mixed small cell and non-small cell cancer
Patients currently receiving potent inducers of CYP3A4
Patients with known or increased risk factor for QTc prolongation
Treatment with any of the following
Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
Prior treatment with neoadjuvant or adjuvant EGFR TKI
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
Any of the following cardiac criteria
Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
Main Cohort Exclusion Criteria
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
History of allogeneic organ transplantation
History of another primary malignancy with exceptions
History of active primary immunodeficiency
Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
Prior exposure to immune-mediated therapy with exceptions
Osimertinib Cohort Key Exclusion Criteria
Mixed small cell and non-small cell cancer
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