NVL-520-01: A Phase 1/2 study of the highly selective ROS1 inhibitor NUV-520 in patients with advanced NSCLC and other solid tumors (ARROS-1).
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Lung CancerAdvanced Ros1-positive Nsclc And Other Advanced Ros1-positive Solid Tumors
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Phase 2 Cohort 2e only: Age =12 years and weighing > 40 kg. (Patients ages 12 to 17 will only be enrolled in countries and at sites where regulations allow.)
- 2. Disease criteria a. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement, determined by testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) and using a local diagnostic test or a commercial test or by a regulatory agency approved test, such as fluorescence in situ hybridization (FISH) or next generation sequencing (NGS) or reverse transcription polymerase chain reaction (RT-PCR). The report from this test is required to be submitted for eligibility. b. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement as determined by testing in a CLIA or equivalently accredited diagnostic lab using a local diagnostic test or a commercial test or by a regulatory agency approved test, such as FISH or NGS or RT-PCR. The report from this test is required to be submitted for eligibility. c. Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2d) with ROS1 rearrangement as determined by testing in a CLIA or equivalently accredited diagnostic lab using a local diagnostic test or a commercial test or by a regulatory agency approved test, such as FISH or NGS or RT-PCR. The report from this test is required to be submitted for eligibility.
You may not be eligible for this study if the following are true:
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- 1. Patient’s cancer has a known oncogenic driver alteration other than ROS1. For example, NSCLC with a targetable mutation in EGFR, ALK, MET, RET, or BRAF; colorectal with an oncogenic KRAS, NRAS, or BRAF mutation. Investigators should discuss enrollment with the Sponsor regarding co-mutations.
- 2. Known allergy/hypersensitivity to excipients of NVL-520.
- 3. Major surgery within 4 weeks of first dose of study drug. Minor surgical procedures (eg, port insertion) are permitted, but with sufficient time for wound healing as deemed clinically appropriate.
- 4. Ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug (NVL-520 may be started within limits for prior TKI or chemotherapy if considered by the Investigator to be safe and within the best interest of the patient, with prior approval from the Sponsor): a. TKI or other anticancer therapy (excluding chemotherapy, immunotherapy, or cellular therapy for which guidance is given below) <5 half-lives or <7 days, whichever is longer b. Chemotherapy <21 days c. Immunotherapy or cellular therapy <28 days
- 5. Ongoing or recent radiation therapy within the following timeframe prior to first dose of study drug
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