Treatment for advanced ALK-positive non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial is a multicenter, randomized, controlled, open-label study aimed at comparing the efficacy of neladalkib (NVL-655) against alectinib in prolonging progression-free survival in treatment-naïve patients with advanced ALK-positive non-small cell lung cancer (NSCLC). Approximately 450 participants will be randomly assigned in a 1:1 ratio to receive either neladalkib or alectinib. The study focuses on patients with confirmed ALK rearrangement and measurable disease, ensuring a robust evaluation of the new treatment's effectiveness.

Why it matters

Who can join: the full rules

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:

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

Where it's running

• Palo Verde Hematology Oncology
  Glendale, Arizona, United States Recruiting
• Hoag Hospital Newport Beach
  Newport Beach, California, United States Recruiting
• University of California, Irvine Health
  Orange, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Boulder, Colorado, United States Recruiting
• Sylvester Comprehensive Cancer Center Miami
  Miami, Florida, United States Recruiting
• AdventHealth Cancer Institute
  Orlando, Florida, United States Recruiting

+109 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nuvalent Clinical Trials
• Email: clinicaltrials@nuvalent.com
• Phone: 857-357-7000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.