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RecruitingLast updated: 16 February 2026

ALKAZAR: Comparing two targeted therapies (neladalkib and alectinib) to see which is more effective at prolonging progression-free survival in people with ALK+ advanced non-small cell lung cancerA Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

ALKAZAR

Clinical summary

Summary

This trial is trying to demonstrate whether neladalkib superior to alectinib in prolonging progression-free survival in people with treatment-naive, ALK-positive, advanced non-small cell lung cancer.

You may be eligible for this study if you have locally advanced or metastatic non-small cell lung cancer that is ALK. You cannot have had prior treatment for non-small cell lung cancer - however adjuvant/neoadjuvant chemotherapy is allowed if it was 12 months prior randomisation in the study. Prior ALK inhibitor treatment is not allowed in any setting.

Eligible participants will be randomly allocated (by chance) to either receive neladalkib orally once daily or alectinib orally twice daily.

Conditions

This trial is treating people with advanced or metastatic ALK+ non-small cell lung cancer

Eligibility

Inclusion

  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

  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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Nuvalent Inc.

Scientific Title

A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

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