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) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation (PACIFIC-4)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2028
  • participants needed
    733
  • sponsor
    AstraZeneca
Updated on 28 October 2022
EGFR
stereotactic body radiation therapy
durvalumab
osimertinib
lung carcinoma

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.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

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
Treatment Placebo, SBRT, durvalumab, Osimertinib (single-arm, open-label)
Clinical Study IdentifierNCT03833154
SponsorAstraZeneca
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18 years
Planned SoC SBRT as definitive treatment
World Health Organization (WHO)/ECOG PS of 0, 1, or 2
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)
Submission of available tumor tissue sample
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)
Patients with central or peripheral lesions are eligible
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

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
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
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