Phase 2 Lung Cancer Trial, Recruiting NCT06631989 Sponsor: Wayshine Biopharm, Inc. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06631989
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:

  • People aged 18 to 75 years old (any gender)
  • People who have been diagnosed through pathology testing with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread or cannot be surgically removed)
  • People whose genetic testing has confirmed a specific type of EGFR mutation (a change in a gene linked to lung cancer)
  • People who can provide a blood sample taken during or after their cancer worsened while on their most recent EGFR-targeted treatment
  • People with a life expectancy of at least 3 months
  • People who have at least one measurable tumour that meets specific imaging criteria (previously treated with radiotherapy only counts if clear new growth is shown on imaging)
  • People with a physical performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity
  • People whose major organs (such as liver, kidneys, and heart) are functioning adequately
  • People who are capable of having children and agree to use reliable contraception during the trial
  • People who are willing to give written informed consent before joining the study

Who may not be able to join:

  • People who have received chemotherapy, radiotherapy, biological therapy, targeted therapy, hormone therapy, immunotherapy, or other anti-cancer treatments within 4 weeks before starting the study drug
  • People who have previously been treated with more than one EGFR-targeted therapy
  • People who have taken part in another clinical trial or received an unlisted experimental treatment within 4 weeks before starting the study drug
  • People who have had major surgery (not including needle biopsies) or a serious injury within 4 weeks before starting the study drug, or who are expected to need planned surgery during the trial
  • People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 7 days before starting the study drug (confirm with trial site)
  • People with known active brain metastases (cancer that has spread to the brain) or evidence of brain tumour progression
  • People who have had another primary cancer diagnosed within the past 2 years
  • People who still have side effects from previous cancer treatments that have not resolved to a mild level, with some exceptions such as hair loss or certain stable conditions (confirm with trial site)
  • People with skin ulcers, pressure sores, chronic leg ulcers, known active stomach ulcers, or wounds that are not healing
  • People with a history of severe allergic reactions, or known allergy to any ingredient in the study drug
  • People with a severe active infection requiring intravenous antibiotics or hospitalisation at the time of screening, or an uncontrolled active infection within 4 weeks before starting the study drug
  • People with known active or suspected autoimmune diseases, or known active eye diseases such as wet age-related macular degeneration or diabetic eye disease affecting the centre of vision
  • People who test positive for HIV or syphilis
  • People with interstitial lung disease (a condition causing scarring or inflammation in the lungs)
  • People with a history of serious heart or cardiovascular disease
  • People who are unable to swallow tablets or capsules, or who have a condition that significantly affects how medication is absorbed through the digestive system
  • People who require medical intervention for fluid build-up around the lungs or in the abdomen (unless the fluid has been stable for more than 2 weeks after drainage and no further drainage is needed)
  • People with known dependence on alcohol or drugs
  • People with mental health conditions or who are unlikely to follow the trial requirements
  • Women who are pregnant or breastfeeding
  • People the trial investigator considers unsuitable for the trial for other reasons

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 22 July 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.

Contact this trial

Principal Investigator: Caicun Zhou, MD, Shanghai East Hospital

Phone: +8613818880308

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
Wayshine Biopharm, Inc.
Registry
ClinicalTrials.gov
Start date
4 September 2024
Est. completion
30 June 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

ORR by IRC; PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC; PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC; PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC; PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC

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: 22 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