Phase 3 Lymphoma Trial, Recruiting NCT06765109 Sponsor: Nuvalent Inc. Condition: Lymphoma
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Phase 3 Lymphoma Trial, Recruiting

NCT06765109
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be treated with a combination of treatments) confirmed by a lab test on a tissue or blood sample
  • People whose lung cancer has a specific genetic change called an ALK rearrangement, confirmed through testing of tissue or blood
  • People who have not previously received systemic (whole-body) cancer treatment for this lung cancer — though chemotherapy given before or after surgery is allowed if it was completed at least 12 months before joining the trial; prior treatment with ALK-targeting drugs (such as alectinib) is not allowed under any circumstances
  • People who have at least one measurable area of cancer that can be tracked using standard imaging criteria
  • People who can provide a tumour tissue sample taken before the trial begins

Who may not be able to join:

  • People whose cancer has a known genetic driver other than the ALK rearrangement
  • People with a known allergy or sensitivity to the ingredients in either of the study drugs (neladalkib or alectinib)
  • People who have recently received or are currently receiving radiation therapy within timeframes specified by the trial protocol (confirm with trial site)
  • People who have had major surgery within 4 weeks before joining the trial
  • People who have an active, uncontrolled infection that requires treatment with systemic (whole-body) medicines
  • People with known active tuberculosis, or active Hepatitis B or Hepatitis C infection
  • People with a specific heart rhythm measurement (QTcF) above 470 milliseconds on repeated checks, which may indicate a heart electrical problem
  • People with a significant heart or cardiovascular condition
  • People with brain metastases (cancer that has spread to the brain) that are causing worsening neurological symptoms or require increasing doses of steroid medicines to manage
  • People who have had another active cancer requiring treatment within the 2 years before joining the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Kelly Curtis, MD, Nuvalent Inc.

Phone: 857-357-7000

Australian sites

Westmead Hospital, Westmead, New South Wales
Austin Health, Heidelberg, Victoria
Peter MacCallum Cancer Centre, Melbourne,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Nuvalent Inc.
Registry
ClinicalTrials.gov
Start date
17 July 2025
Est. completion
1 December 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-free survival (PFS) per blinded independent central review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov