RecruitingNon-small Cell Lung CancerAnaplastic Lymphoma Kinase-positive

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

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Sponsor: Nuvalent Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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