Advanced ALK-positive non-small cell lung cancer
Conditions
Interventions
Patients will receive 150 mg of NVL-655 orally once daily, or 600 mg of Alectinib orally twice daily, and continue treatment until symptomatic deterioration, development of unacceptable toxicity, or o
Sponsors
Tsutsui Toshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease 10. Active malignancy requiring therapy within 2 years prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression -free survival (PFS), defined as the time from randomization to blinded independent central review (BICR)-assessed radiographic disease progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time from randomization to death. Progression-free survival (PFS) per investigator assessment, defined as the time from randomization to investigator-assessed radiographic disease progression or death. Time to intracranial progression, defined as the time from randomization to the first BICR-assessed occurrence of disease progression in the central nervous system (CNS) . Intracranial objective response rate (IC-ORR), defined as the proportion of patients with a confirmed intracranial response (intracranial complete response [IC-CR] or intracranial partial response [IC-PR], among patients with measurable CNS disease at baseline Intracranial duration of response (IC-DOR), defined as the time from first intracranial response (IC-CR or IC-PR) to radiographic intracranial disease progression or death. Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR). Duration of response (DOR), defined as the time from first response (CR or PR) to radiographic disease progression or death Time to intracranial progression per investigator assessment. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Malaysia, Mexico, Netherland, Poland, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, UK, USA
Contacts
Public ContactToshio Tsutsui
PPD-SNBL K.K.
Outcome results
None listed