Phase 2 Lung Cancer Trial, Recruiting NCT06378892 Sponsor: Centro di Riferimento Oncologico - Aviano Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06378892
Recruiting Phase 2

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:

  • You have been diagnosed with advanced (stage IV) non-small cell lung cancer (NSCLC) that has a specific genetic change called ALK-positive, confirmed by a lab test.
  • Your cancer has started growing or spreading outside the brain while you are taking the drug Lorlatinib (it does not matter how many other treatments you have had before).
  • You are at least 18 years old at the time of signing the consent form.
  • You are generally able to carry out daily activities with little or no restriction (confirm with trial site regarding the specific fitness scale used).
  • Your cancer can be measured on scans (CT and MRI).
  • Scans confirm that your cancer is progressing in multiple areas outside the brain, but your brain either has no cancer spread or any brain involvement has been stable on Lorlatinib and/or targeted radiation treatment.
  • Your kidneys, liver, and bone marrow are working well enough as shown by blood tests.
  • Your life expectancy is estimated to be at least 3 months, regardless of your lung cancer diagnosis.
  • If you could become pregnant, or if your partner could become pregnant, you agree to use highly effective contraception during the trial and for at least 6 months after the last dose of study treatment.

Who may not be able to join:

  • You have had a known allergic reaction to any of the drugs or substances used in this trial.
  • You have been diagnosed with another cancer in the past 3 years (with some exceptions, such as certain treated skin cancers, cervical changes, or a previous cancer you have been fully clear of for at least 3 years — confirm with trial site).
  • The trial doctor does not consider you suitable for a combination treatment of chemotherapy and Lorlatinib.
  • You are experiencing side effects from Lorlatinib that would make it unsafe to continue taking it.
  • You are currently taking certain medications that strongly affect how the body processes a specific group of drugs (called potent CYP3A4/5 inducers — confirm with trial site which medications are included).

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 30 June 2026
Phase 2: approximately ~30% 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Centro di Riferimento Oncologico - Aviano
Registry
ClinicalTrials.gov
Start date
15 March 2024
Est. completion
1 May 2028

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib.

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: 30 June 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