Phase 1 Lung Cancer Trial, Not Yet Recruiting NCT06218940 Sponsor: Newsoara Biopharma Co., Ltd. Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Not Yet Recruiting

NCT06218940
Not Yet Recruiting Phase 1

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 given signed and dated written consent before any study procedures begin (declining the optional research or genetic parts of the study will not affect participation in the rest of the trial).
  • People who are at least 18 years old.
  • People who have a confirmed diagnosis (through tissue or cell testing) of a locally advanced or metastatic solid tumour.
  • People who have a documented EGFR mutation (a specific genetic change in the tumour) before joining the combination therapy part of the trial.
  • People whose treating doctor determines them eligible for treatment with osimertinib before joining the combination therapy part of the trial.
  • People with a general health score of 0–2 on the World Health Organization scale (meaning able to carry out daily activities with at most some limitations), with no worsening in the previous 2 weeks, and a life expectancy of at least 12 weeks.
  • People who have at least one tumour lesion that has not been previously treated with radiation, has not been biopsied during the study screening period, and can be measured at 10 mm or more in its longest diameter (or at least 15 mm for lymph nodes) using CT or MRI scanning.

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 recently taken an EGFR-targeting drug (such as erlotinib, gefitinib, or osimertinib) within 8 days — or within approximately 5 times that drug's clearance time from the body, whichever is longer — before the first dose of study treatment (confirm with trial site if wash-out timing is unclear).
  • People who have received chemotherapy, another investigational drug, or other anticancer medicines within 14 days before the first dose of study treatment.
  • People who have had major surgery (not including placement of a drip or port) within 4 weeks before the first dose of study treatment.
  • People who have received limited-field radiotherapy for pain relief within 1 week before the first dose of study treatment, or wider-field radiotherapy (covering more than 30% of the bone marrow) that was not completed at least 4 weeks before the first dose.
  • People with previously untreated non-small cell lung cancer (NSCLC) who are not eligible for osimertinib treatment, as eligibility for osimertinib is required to join the combination therapy cohorts.
  • People who still have unresolved side effects from previous treatment that are rated above Grade 1 severity at the time of starting the study, except for hair loss or Grade 2 nerve-related side effects from prior platinum-based chemotherapy.
  • People with spinal cord compression or brain metastases, unless these are causing no symptoms, are considered stable, and have not required steroid treatment for at least 4 weeks before starting the study.
  • People with severe or uncontrolled health conditions — including uncontrolled high blood pressure, active uncontrolled bleeding, or active infections such as hepatitis B, hepatitis C, or HIV — that the investigating doctor believes would make participation unsafe or make it difficult to follow the study requirements.
  • People with any of the following heart-related findings: a corrected QT interval (a measure of heart electrical activity) averaging more than 470 milliseconds across 3 ECG readings; certain significant abnormalities in heart rhythm or electrical conduction seen on a resting ECG; or factors that raise the risk of dangerous heart rhythm problems, such as heart failure, low potassium levels, a personal or close family history of long QT syndrome, unexplained sudden death in a first-degree relative under age 40, or use of medicines known to affect the QT interval.
  • People with a history of a type of lung disease called interstitial lung disease that was caused by an EGFR-targeting drug (other forms of interstitial lung disease that have not been clinically active in the last 6 months before screening may be considered).

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 29 July 2026

Contact this trial

Principal Investigator: Hannah Chen, Sponsor GmbH

Phone: 862152998027

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 1
Sponsor
Newsoara Biopharma Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
1 December 2026

Primary endpoints

Evalute safety, tolerability of HY1272 in patients from day 1 to end of study.; Evalute PK of HY1272 in patients from week 1 to week 3.

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: 29 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