Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Launched by NUVALENT INC. · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called neladalkib (NVL-655) to see if it can help patients with advanced non-small cell lung cancer (NSCLC) who have not received any cancer treatment before. Specifically, the trial is looking at whether neladalkib works better than another medication called alectinib in helping to keep the cancer from worsening. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with advanced ALK-positive NSCLC, which means their cancer cells have a specific genetic change that can be targeted with these treatments.

To be eligible for this trial, patients must have confirmed advanced NSCLC that hasn’t been treated with any previous anti-cancer medications, except for some chemotherapy that was given more than a year ago. They will also need to have measurable cancer growth and tissue samples available for testing. Participants can expect regular check-ups and monitoring during the trial to assess how well the medication is working and to ensure their safety. It's important to know that certain health conditions and previous treatments may prevent someone from joining the trial, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 1. Patient's cancer has a known oncogenic driver alteration other than ALK.
• • 2. Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
• • 3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
• • 4. Major surgery within 4 weeks prior to randomization
• • 5. Uncontrolled clinically relevant infection requiring systemic therapy
• • 6. Known active tuberculosis, or 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