Phase 2 Lung Cancer Trial, Recruiting NCT04996121 Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT04996121
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

  • Adults aged 18 or older
  • People with an advanced or metastatic solid tumour (cancer that has spread) that has been confirmed by tissue or cell testing, where standard treatments no longer work, are not suitable, or have caused intolerance — or, for later stages of the trial, people whose tumour has tested positive for a specific gene change called NTRK or ROS1 fusion, confirmed by a qualified laboratory
  • Depending on the stage of the trial, people may need to have a specific type of cancer: an NTRK fusion-positive solid tumour, or a type of lung cancer (NSCLC) with a ROS1 gene fusion — either after prior treatment with a drug called crizotinib, or without having received crizotinib before
  • People who have at least one measurable tumour lesion, as assessed using standard medical imaging guidelines (RECIST v1.1)
  • People with a good general health status, rated 0 or 1 on the ECOG performance scale — meaning fully active or able to carry out light activity (confirm with trial site)
  • People with a life expectancy of at least 3 months
  • People whose blood, kidney, and liver test results meet certain minimum levels, indicating the organs are functioning adequately
  • People who are able to use reliable contraception throughout the trial and for 90 days after the last dose; women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the trial

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 have received anti-cancer treatments such as chemotherapy, radiation, immunotherapy, or hormone therapy within the 4 weeks before starting the trial (different timeframes apply for certain specific drugs — confirm with trial site)
  • People who have taken part in another trial using an unapproved drug or treatment within the 4 weeks before starting
  • People who have had major surgery (other than a biopsy) or a serious injury within the 4 weeks before starting, or who are expected to need planned surgery during the trial
  • People who still have significant side effects from previous cancer treatment that have not sufficiently resolved (with some exceptions such as hair loss or stable thyroid conditions)
  • People who are unable to swallow tablets or capsules, or who have a condition that severely affects the ability to absorb oral medication, such as chronic diarrhoea or bowel obstruction
  • People with brain or meningeal (lining of the brain) metastases that are causing active symptoms — those with stable, symptom-free brain metastases that have not required steroid treatment for more than 4 weeks may still be considered (confirm with trial site)
  • People with active infections currently requiring intravenous (IV) antibiotic or antiviral treatment
  • People with a history of immune deficiency conditions, or who test positive for HIV
  • People with active Hepatitis B or active Hepatitis C infection
  • People with a known lung condition called interstitial lung disease (with some exceptions — confirm with trial site)
  • People with a history of serious heart or cardiovascular disease
  • People who are pregnant or breastfeeding

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

Contact this trial

Principal Investigator: Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phone: +86-13811667040

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 2
Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
6 December 2021
Est. completion
1 September 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.

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Maximum tolerated dose (MTD) (Phase I dose escalation); Number of patients with adverse events (Phase I dose escalation); Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) (Phase I dose expansion and phase II)

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