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.

NCT05170204 : A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase III study is evaluating how safe and effective different therapies (including alectinib, entrectinib, pralsetinib, and durvalumab) are in people with non-small cell lung cancer with eligible biomarker status.
 

This trial is treating patients with non-small cell lung cancer that is either ALK-positive, ROS 1-positive, or RET fusion-positive.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

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.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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 I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

Commercial Sponsor

Hoffmann-La Roche

Summary

Eligible participants will be allocated to one of three cohorts depending on their cancer's biomarker status. Within each cohort, participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. Cohort A1 is for ALK-Positive participants. In the Cohort A1 Experimental Arm, participants will receive alectinib (600mg) orally twice daily. In Cohort A1 Active Comparator Arm, participants will receive durvalumab (1500mg) intravenously every 4 weeks. Cohort A2 is for ROS 1-positive participants. In the Cohort A2 Experimental Arm, participants will receive entrectinib (600mg) orally once daily. In Cohort A2 Active Comparator Arm, participants will receive durvalumab (1500mg) intravenously every 4 weeks. Cohort A3 is for RET fusion-positive participants. In the Cohort A3 Experimental Arm, participants will receive pralsetinib (400mg) orally once daily. In the Cohort A3 Active Comparator arm, participants will receive durvalumab (1500mg) intravenously once every 4 weeks.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Rachel McMenamin
PCCTU.MoncB@petermac.org

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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