Phase 2 Lung Cancer Trial, Recruiting NCT07264816 Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT07264816
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:

  • You are willing to sign a consent form and follow the study rules
  • You are between 18 and 75 years old
  • You have no gender restrictions — anyone may apply
  • Your doctors expect you to live for at least 3 more months
  • You have been diagnosed with locally advanced or metastatic non-squamous non-small cell lung cancer (a specific type of lung cancer that has spread)
  • Your cancer has been confirmed to have high levels of a protein called HER2
  • You are able to provide a stored tumor tissue sample from the past 2 years
  • You have at least one area of cancer that can be measured on a scan
  • You are generally able to carry out daily activities with little or no restriction (confirm with trial site)
  • Any side effects from previous cancer treatments have mostly gone away
  • Your heart is pumping well, with no serious heart problems
  • Your organs (such as kidneys and liver) are functioning at an acceptable level (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting the trial and not be breastfeeding; all participants must use effective contraception during treatment and for 7 months after it ends

Who may not be able to join:

  • You had surgery, intensive radiotherapy, immunotherapy, or similar treatments within the past 4 weeks (or within a certain time based on the treatment used)
  • Your cancer pathology shows it also contains small cell carcinoma or sarcomatoid carcinoma components (specific cancer subtypes)
  • You have previously been treated with HER2-targeted therapies or a specific type of antibody-drug treatment (confirm with trial site)
  • You had a serious heart or stroke-related event in the past 6 months
  • You have another lung disease that is severely affecting your breathing
  • You have certain heart rhythm or electrical problems, such as a prolonged QT interval or serious heart block (confirm with trial site)
  • You have been diagnosed with another type of cancer within the past 5 years
  • You have high blood pressure that is not well controlled
  • You have a history of a type of lung inflammation (non-infectious ILD) that required steroid treatment, or you currently have lung inflammation
  • You have cancer that has spread to the brain, the lining of the brain, or the spinal cord
  • You have had allergic reactions to certain antibody-based medicines, or to the specific drugs used in this trial
  • You needed steroid or immune-suppressing medicines within the past 2 weeks
  • You have large, symptomatic, or poorly controlled fluid build-up around your organs (such as around the lungs or heart)
  • You developed a new deep vein blood clot (DVT) within the past 14 days (unless you have a venous filter in place)
  • You had a serious body-wide infection within the past 4 weeks
  • You have an active autoimmune or inflammatory disease
  • You are HIV positive, or have active hepatitis B or hepatitis C infection
  • You have had a bone marrow, stem cell, or organ transplant in the past
  • You have a serious neurological or psychiatric condition
  • You have other significant health problems or abnormal test results that the trial doctor believes would make participation unsafe or unsuitable

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 June 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
3 February 2026
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR); Combined optimal dosage; Combination method

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 June 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