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A Study in TKI-naive Patients With Advanced ALK-Positive NSCLC ( ALKAZAR )
EU CTIS ID: 2024-517553-26-00
What this study is testing
To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC
- 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
- Patients must meet all of the following criteria to be eligible to enroll in the study: 1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 3. No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting) 4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) 5. Pretreatment tumor tissue (archived or a fresh biopsy)
You likely can't join if
- 1. Patient’s cancer has a known oncogenic driver alteration other than ALK. 2. Known allergy/hypersensitivity to excipients of NVL-655 or alectinib. 3. Major surgery within 4 weeks prior to randomization 4. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization 5. Uncontrolled clinically relevant infection requiring systemic therapy 6. Known active tuberculosis, known active Hepatitis B or C 7. QT corrected for heart rate by Fridericia’s formula (QTcF) > 470 msec on repeated assessments 8. Clinically significant cardiovascular disease 9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease 10. Active malignancy requiring therapy within 2 years prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Korea, Republic of
- Mexico
- Japan
- Singapore
- Hong Kong
- Thailand
- Argentina
- Canada
- Malaysia
- United Kingdom
- Brazil
- Australia
- United States
- Taiwan
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Korea, Republic of; Mexico; Japan; Singapore; Hong Kong and 9 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.