BridgeMD
A study to test the efficacy and safety of Lazertinib in the treatment of patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
EU CTIS ID: 2024-514771-18-00
What this study is testing
To assess the efficacy of lazertinib compared with gefitinib as measured by progression-free survival
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pathologically confirmed adenocarcinoma of the lung
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
- Treatment-naïve for locally advanced or metastatic NSCLC
- WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
- At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period
You likely can't join if
- Symptomatic and unstable brain metastases
- Leptomeningeal metastases
- Symptomatic spinal cord compression
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Any medical conditions requiring chronic continuous oxygen therapy
- History of any malignancy other than the disease under study within 3 years before randomization
See the full eligibility criteria
- Pathologically confirmed adenocarcinoma of the lung
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
- Treatment-naïve for locally advanced or metastatic NSCLC
- WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
- At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period
- Symptomatic and unstable brain metastases
- Leptomeningeal metastases
- Symptomatic spinal cord compression
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Any medical conditions requiring chronic continuous oxygen therapy
- History of any malignancy other than the disease under study within 3 years before randomization
- Any cardiovascular disease as follows: History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment History of myocardial infarction or unstable angina within 24 weeks of randomization
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Ukraine
- Thailand
- Philippines
- Australia
- Malaysia
- Turkey
- Singapore
- Serbia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Ukraine; Thailand; Philippines; Australia; Malaysia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.