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Nuvalent’s Promising Phase 3 Study: A Potential Game-Changer in NSCLC Treatment

Nuvalent’s Promising Phase 3 Study: A Potential Game-Changer in NSCLC Treatment

Nuvalent, Inc. Class A ((NUVL)) announced an update on their ongoing clinical study.

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Nuvalent, Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR).’ The study aims to demonstrate that neladalkib (NVL-655) is more effective than alectinib in prolonging progression-free survival in patients with treatment-naïve, ALK-positive advanced non-small cell lung cancer (NSCLC).

The study is testing two drugs: neladalkib (NVL-655), an experimental oral tablet taken once daily, and alectinib, an active comparator oral capsule taken twice daily. Both drugs are designed to inhibit the anaplastic lymphoma kinase (ALK) to treat advanced NSCLC.

This is a multicenter, randomized, controlled, open-label study with a parallel intervention model. It is single-masked, with the outcomes assessor being the only party blinded. The primary purpose of the study is treatment-focused.

The study began recruiting on November 8, 2024, with the last update submitted on October 17, 2025. These dates are crucial as they indicate the study’s progression and the timeline for potential results.

For investors, this study could significantly impact Nuvalent’s stock performance, as successful results may enhance the company’s market position against competitors in the ALK-positive NSCLC treatment space. Positive outcomes could lead to increased investor confidence and potential market share growth.

The study is ongoing, and further details are available on the ClinicalTrials portal.

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