Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

ThreePhase Three

18-130Age 18-130

Lung<br/>CancersCancer LocationLung
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy,Treatment | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This study is assessing how safe and effective immunotherapy plus radiation therapy is, compared to placebo and radiation therapy, in people with lymph-node negative non-small cell lung cancer.
 

This trial is treating patients with lymph-node negative non-small cell lung cancer.

This is a systemic therapy and radiation therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Commercial Sponsor

AstraZeneca

Summary

The main part of this study is recruiting people with stage I/II lymph node negative (T1 to T3N0M0) non-small cell lung cancer who have not had prior therapy. This main study will randomly assign eligible participants to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive standard-of-care stereotactic body radiation therapy (SBRT) plus immunotherapy (durvalumab). SBRT will be delivered in 3, 4, 5 or 8 fractions. Durvalumab will be given at a dose of 1500mg every 4 weeks intravenously. In the Placebo Comparator Arm, participants will receive standard of care SBRT plus a placebo. SBRT will be delivered in 3, 4, 5 or 8 fractions. The Placebo will be given every 4 weeks via IV. In addition to this main study, an additional cohort will recruit participants with stage I/II lymph node-negative non-small cell lung cancer harbouring an EGFR mutation who have not had prior therapy. This cohort will receive standard of care SBRT followed by targeted therapy (osimertinib). SBRT will be delivered in 3, 4, 5 or 8 fractions. Osimertinib will be given at a dose of 80mg every day via oral tablet for up to 36 months.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Lung and Head & Neck Research Study Coordinator
lung.oncresearch@monashhealth.org
0417607146

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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