Non-small Cell Lung Cancer study: Neladalkib vs Alectinib
Official title Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
ClinicalTrials.gov ID: NCT06765109
What this study is testing
What is Neladalkib (NVL-655)?
This is an investigational oral tablet being studied as a potential treatment for advanced non-small cell lung cancer. is designed to block a specific protein called ALK that helps cancer cells grow.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether neladalkib can keep advanced ALK‑positive non‑small cell lung cancer from progressing longer than alectinib does.
- Who it's for
- It is looking for adults with advanced ALK‑positive non‑small cell lung cancer who have not yet received any treatment for this cancer.
- What's involved
- Participants will receive neladalkib or alectinib and will have regular clinic visits and tests to monitor the cancer and any side effects.
- Time commitment
- The study lasts until the cancer progresses or the participant drops out, with visits every few weeks for medication and monitoring.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
- Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
- No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization
- Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- Pretreatment tumor tissue
You likely can't join if
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
- Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- Major surgery within 4 weeks prior to randomization
- Uncontrolled clinically relevant infection requiring systemic therapy
- Known active tuberculosis, or active Hepatitis B or C
See the full eligibility criteria
- Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
- Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
- 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)
- Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- Pretreatment tumor tissue
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
- Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- Major surgery within 4 weeks prior to randomization
- Uncontrolled clinically relevant infection requiring systemic therapy
- Known active tuberculosis, or active Hepatitis B or C
- QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 msec on repeated assessments
- Clinically significant cardiovascular disease
- Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
- Active malignancy requiring therapy within 2 years prior to randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, Arizona, United States
- Newport Beach, California, United States
- Orange, California, United States
- Boulder, Colorado, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Westbury, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Sellersville, Pennsylvania, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
+ 114 more site(s).
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, Arizona, United States; Newport Beach, California, United States; Orange, California, United States; Boulder, Colorado, United States; Miami, Florida, United States; Orlando, Florida, United States and 128 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.