Clinical trial · Expanded Access
Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| ROS1-positive Non-Small Cell Lung Cancer (NSCLC) | ROS1-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NVL-520 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement. 3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician. 4. Enrollment in a clinical trial of zidesamtinib is not possible. 5. Adequate organ function and bone marrow reserve. Exclusion Criteria: 1. Prior receipt of zidesamtinib. 2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol. 3. Ongoing anti-cancer therapy. 4. Eligible for ongoing clinical trial with zidesamtinib
References
Publications (0)
Data not yet available