Lung Cancer Trial, Not Yet Recruiting NCT07418879 Sponsor: Fudan University Condition: Lung Cancer
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Lung Cancer Trial, Not Yet Recruiting

NCT07418879
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults aged 18 or older, of any sex.
  • People who have not yet received any treatment and have been diagnosed through a tissue sample with a type of lung cancer called lung adenocarcinoma that has either spread to nearby areas or to other parts of the body, and cannot be removed by surgery or fully treated with radiotherapy.
  • People whose lung cancer has tested positive for a specific genetic change called a RET fusion.
  • People with advanced or spread lung cancer who have not yet received any systemic (whole-body) anti-cancer treatment, and whose cancer has been assessed by a doctor as unsuitable for surgery or radiotherapy.
  • People whose blood test results show the body's organs are working well enough, including adequate levels of white blood cells, platelets, and red blood cells, as well as acceptable liver and kidney function (confirm specific numbers with trial site).
  • People who are reasonably well and able to carry out daily activities, as measured by a standard scoring system called the ECOG Performance Status (scored 0–2), with no major worsening in the two weeks before joining.
  • People whose doctors expect them to survive for more than 12 weeks from the start of treatment.
  • People of reproductive age who are not currently pregnant, do not plan to become pregnant, and agree to use effective contraception throughout the study and for six months after stopping the study drug — this applies to both women of reproductive age and men.
  • People who understand the study, agree to take part voluntarily, and sign a consent form.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose lung cancer is a different type, such as squamous cell lung cancer, small cell lung cancer, neuroendocrine carcinoma, or similar cancers confirmed by tissue or cell testing.
  • People who have had major surgery within four weeks before starting the study drug, or who are planning major surgery during the trial (minor procedures such as placing a line for medication, or biopsy procedures, are not included); or people who have recently taken certain medications that affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers), or who have taken certain traditional Chinese herbal medicines used for cancer treatment, within specified timeframes before starting the study.
  • People who have pressure on the spinal cord, or cancer that has spread to the lining around the brain or spinal cord and is causing symptoms.
  • People who have fluid build-up around the lungs or in the abdomen that is causing symptoms and is not stable — though people whose symptoms have been stable for at least 14 days after having the fluid drained may be considered.
  • People who have had another type of cancer in the past or currently have another cancer at the same time, unless that cancer was fully treated by surgery more than five years ago with no return (for example, certain cervical, skin, or thyroid cancers).
  • People who have a history of a lung condition called interstitial lung disease (ILD), lung inflammation caused by medication, or lung inflammation from radiation that needed steroid treatment, or who currently show signs that could suggest interstitial lung disease.
  • People who have serious or poorly controlled health conditions that a doctor considers unsafe for trial participation, including uncontrolled high blood pressure, diabetes, severe heart failure, unstable chest pain, a heart attack within the past year, active bleeding, or other serious conditions.
  • People whose heart's electrical activity, measured by an ECG, shows a particular reading called a QTc interval above 470 milliseconds.
  • People who have certain heart rhythm problems or conditions that may increase the risk of a specific heart electrical problem (QT interval prolongation), such as a specific type of heart block, a condition present from birth affecting heart rhythm, very low potassium levels, or who are taking other medicines that may affect heart rhythm.
  • People who have serious digestive system problems or other conditions that may affect how the study drug is absorbed into the body.
  • People who have an infection that requires treatment through a drip (intravenous medication).
  • People who are known or believed to be allergic to the study drug (Pralsetinib) or any of its ingredients.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study; or male participants whose female partners are planning to become pregnant during the study.
  • People who are unlikely to be able to follow the study's requirements and procedures as needed.
  • People who a doctor considers unsuitable for the study for any other reason.

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 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 021-64175590

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
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
5 February 2026
Est. completion
31 December 2027

Primary endpoints

The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib

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 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