4 recruiting, 2 available. 3 Phase 1, 2 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Recruiting 3 |
| Phase 2 | 2 | Recruiting 2 |
| Phase 3 | 1 | Recruiting 1 |
Follow Nuvalent Inc.: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Neladalkib (NVL-655), Alectinib - Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive | Phase 3 | Recruiting | Nuvalent Inc. | 450 | 2025-07-17 | 2026-09-30 |
| A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1) NVL-330 - Locally Advanced Solid Tumor, Metastatic Solid Tumor | Phase 1 | Recruiting | Nuvalent Inc. | 200 | 2024-07-18 | 2026-10-20 |
| A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) Neladalkib (NVL-655), Midazolam, Repaglinide - Locally Advanced Solid Tumor, Metastatic Solid Tumor | Phase 1 / Phase 2 | Recruiting | Nuvalent Inc. | 840 | 2022-06-09 | 2026-05-27 |
| A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) Zidesamtinib (NVL-520) - Locally Advanced Solid Tumor, Metastatic Solid Tumor | Phase 1 / Phase 2 | Recruiting | Nuvalent Inc. | 359 | 2022-01-04 | 2026-09-24 |
| Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors NVL-655 - Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC) | Available | Nuvalent Inc. | 2026-09-21 | |||
| Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors NVL-520 - Non Small Cell Lung Cancer, ROS1-positive Non-Small Cell Lung Cancer (NSCLC) | Available | Nuvalent Inc. | 2026-08-25 |
Carcinoma, Non-Small-Cell Lung (3) · Neoplasm Metastasis (3) · Lung Diseases (1) · Lung Neoplasms (1)
Itraconazole (1) · Midazolam (1) · alectinib (1) · repaglinide (1)
Australia (6) · Canada (6) · France (5) · Italy (5) · Netherlands (5) · Singapore (5) · Spain (5) · Taiwan (5) · United Kingdom (5) · United States (5) · Belgium (4) · South Korea (4) · Germany (3) · Japan (3) · Switzerland (3)
Kelly Curtis, MD (1) · Steve Margossian, MD PhD (1) · Viola Zhu, MD, PHD (1) · Vivek Upadhyay, MD, MBI (1)