Phase 2 Lung Cancer Trial, Not Yet Recruiting NCT05186506 Sponsor: Sichuan University Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Not Yet Recruiting

NCT05186506
Not Yet Recruiting Phase 2

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

  • People who have had surgery to remove non-small cell lung cancer (NSCLC) at Stage IIA to IIIA, where the cancer was fully removed with clear margins, and who are within 10 weeks after that operation.
  • People whose cancer has tested positive for a specific gene change called ALK-positive, confirmed by an approved laboratory test.
  • People who have a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning able to carry out normal daily activities with little or no restriction).
  • People with a life expectancy of at least 3 months.
  • People whose liver, kidneys, and other organs are functioning well enough to safely take part (confirm with trial site).
  • People who have had any major surgery at least 4 weeks before the first study treatment, and any minor surgery or procedures at least 2 weeks before starting medication.
  • People who are willing and able to follow all trial procedures and attend follow-up visits.
  • People who have read and signed an informed consent form showing they understand the investigational nature of the study.

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 who started the trial process more than 10 weeks after surgery, or who have another current cancer or were diagnosed with another cancer in the last 5 years (except for certain skin cancers or cervical cancer in situ).
  • People who have taken another experimental drug within 4 weeks before the first dose of the study drug (Ensartinib).
  • People who have previously had a stem cell or organ transplant.
  • People with serious heart or cardiovascular disease.
  • People with active stomach or bowel conditions, or other conditions that could affect how the study drug is absorbed or processed by the body.
  • People who have active hepatitis B, hepatitis C, HIV, or syphilis (based on positive blood tests).
  • People with a history of certain lung conditions, including interstitial lung disease, lung damage from drugs, or radiation-related lung inflammation that needed steroid treatment, or who currently show signs of active interstitial lung disease.
  • People who are pregnant, breastfeeding, or have a positive pregnancy test within 7 days before starting treatment; also people (male or female) who are not willing to use effective contraception throughout the entire treatment period and for 3 months after treatment ends, or who plan to have a child during that time.
  • People who are known to be allergic or have had a delayed allergic reaction to Ensartinib or to drugs chemically similar to it.
  • People with a known allergy to certain chemotherapy drugs such as pemetrexed, carboplatin or other platinum-based drugs, paclitaxel, or their related medications; or people with uncontrolled asthma.
  • People who have taken, or need to take during the trial, certain medications that can affect heart rhythm (QTc prolongation) or strongly interact with a liver enzyme called CYP3A, within 14 days before the first dose.
  • People currently being treated with warfarin or similar blood-thinning medications.
  • People with other serious, ongoing, or acute medical conditions that the trial investigator believes could increase health risks or affect trial results (confirm with trial site).
  • People who have any other condition that the trial investigator believes makes it unsuitable for them to take part (confirm with trial site).

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 14 July 2026

Contact this trial

Principal Investigator: You Lu, MD, Sichuan University

Phone: +8618980601763

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
Phase 2
Sponsor
Sichuan University
Registry
ClinicalTrials.gov
Start date
1 January 2022
Est. completion
15 December 2025

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Disease free survival (DFS)

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: 14 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