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Taking people in TaiwanPhase 3

Neladalkib Compared With Alectinib for Advanced ALK-Positive Lung Cancer

Tests neladalkib against alectinib in adults with advanced ALK-positive lung cancer, not yet treated.

Key facts

Who runs it
Nuvalent Inc.
Where
Kaohsiung City, Taichung, Tainan, and Taipei, TaiwanSee the 4 sitesAlso in 28 other countries, 161 sites
Registry title
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Status
Recruiting
Phase
Phase 3
People taking part
450 people, planned
Started
17 Jul 2025
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Neladalkib (NVL-655)
  • Alectinib
Record updated
30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced lung cancer (non-small cell) that has an ALK change and who have not yet had cancer drug treatment for it.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced lung cancer that cannot be treated with several methods together, or lung cancer that has spread (metastatic). Measurable disease on scans (1 or more target lesions).
Earlier treatment
No earlier whole-body cancer treatment for this lung cancer. Chemotherapy before or after surgery is allowed if it was 12 months before randomization. Earlier ALK TKI drugs, such as alectinib, are not allowed.
Biomarker or test result
An ALK rearrangement shown by testing tumor tissue or blood. Tumor tissue from before treatment is needed.

Main reasons for not taking part

  • Cancer with a known driver gene change other than ALK
  • Brain metastases with worsening symptoms, or needing increasing steroid doses
  • Active tuberculosis, or active hepatitis B or C
  • Clinically significant heart disease, or QTcF over 470 msec
  • Another active cancer needing treatment within 2 years

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
  • Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
  • 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)
  • Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Pretreatment tumor tissue

Who cannot take part

  • Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
  • Major surgery within 4 weeks prior to randomization
  • Active malignancy requiring therapy within 2 years prior to randomization
  • Patient's cancer has a known oncogenic driver alteration other than ALK
  • Known allergy/hypersensitivity to excipients of neladalkib or alectinib
  • Uncontrolled clinically relevant infection requiring systemic therapy
  • Known active tuberculosis, or active Hepatitis B or C
  • Clinically significant cardiovascular disease
  • Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
  • QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?

Where in Taiwan

Also in 28 other countries, 161 sites

  • Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanContact: Jen-Yu Hung, M.D., Ph.D. (principal investigator)Taking people
  • Chung Shan Medical UniversityTaichung, TaiwanContact: Gee-Chen Chang, M.D., Ph.D. (principal investigator)Taking people
  • National Cheng Kung University HospitalTainan, TaiwanContact: Chien-Chung Lin, M.D., Ph.D. (principal investigator)Taking people
  • National Taiwan University HospitalTaipei, TaiwanContact: Chia-Chi Lin, M.D., Ph.D. (principal investigator)Taking people

About the trial

What the trial wants to find out

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

The 2 groups in the trial

  • Neladalkib (NVL-655)Treatment being tested

    150mg taken orally once daily (QD)

  • AlectinibExisting treatment, for comparison

    600mg taken orally twice daily (BID)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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)
Plain-language title
Neladalkib Compared With Alectinib for Advanced ALK-Positive Lung CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06765109, who can take part
Record updated
30 September 2026