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.

EVOKE-02 : An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy,Treatment | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase II study is seeking to determine the appropriate dose level, safety and effectiveness of targeted therapy (Sacituzumab Govitecan-hziy) in combination with immunotherapy (pembrolizumab) or in combination with immunotherapy and chemotherapy (pembrolizumab, carboplatin and/or cisplatin) in people with advanced or metastatic non-small cell lung cancer.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

Commercial Sponsor

Gilead Sciences, Inc.

Summary

This study consists of 6 experimental cohorts, 2 of which are safety-run in cohorts. In the Safety Run in Cohort for Sacituzumab Govitecan-hziy (SG) + pembrolizumab + carboplatin, participants will receive SG (de-escalating dose levels: 10.0mg/kg, 7.5mg/kg, or 5.0mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle. In the Safety Run in Cohort for SG + pembrolizumab + cisplatin, participants will receive SG (either 10mg/kg or 7.5mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + cisplatin (75mg/m^2) on Day 1 of a 21-day cycle. In the Experimental Cohort A, participants assigned to Cohort A according to tumour proportion score (TPS) status will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle. In the Experimental Cohort B according to TPS status will receive SG (10mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle. In Experimental Cohort C, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. In Experimental Cohort D, participants assigned according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab (200mg) on Day 1 of a 21-day cycle + carboplatin (75mg/m^2) as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. All treatments will be administered intravenously.

Recruiting Hospitals Read MoreRead more

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
CancerClinicalTrials@wh.org.au
0434 915 739

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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