Phase 2 Lung Cancer Trial, Recruiting NCT06475300 Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06475300
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 agree to follow the study rules
  • You are 18 years of age or older (any gender)
  • Your doctors expect you to live for at least 3 more months
  • You have been diagnosed with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma (a type of head and neck cancer), confirmed by a tissue or cell test
  • You are able to provide 6 to 10 tumor tissue samples (either stored samples from the past 2 years or freshly taken samples)
  • You have at least one tumour that can be measured on a scan, meeting specific size guidelines used in cancer research
  • Your general health and ability to carry out daily activities is rated as 0 or 1 on a standard scale (meaning you are fully active or able to do light work)
  • Any side effects from previous cancer treatments have largely resolved or are very mild
  • Your heart is functioning well, with the pumping strength of your heart (left ventricular ejection fraction) at 50% or higher
  • Your blood clotting levels are within an acceptable range
  • Your urine protein levels are within acceptable limits
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants (male or female) are advised to use reliable contraception during treatment and for 6 months after it ends

Who may not be able to join:

  • Certain non-small cell lung cancer patients with a specific gene mutation (EGFR-sensitive) who have already received chemotherapy or other systemic treatment (confirm with trial site for exact details)
  • Patients whose genetic test results show a specific gene change called an ALK fusion, in certain parts of the study (confirm with trial site)
  • You have received chemotherapy, biological therapy, or certain other cancer treatments within the 4 to 6 weeks before joining the trial (the exact time window depends on the type of treatment)
  • You have a serious heart condition
  • You have certain heart rhythm problems, including long QT syndrome, complete left bundle branch block, or severe irregular heartbeat
  • You have an active autoimmune or inflammatory disease (a condition where your immune system attacks your own body)
  • You have been diagnosed with another type of cancer within the past 5 years
  • Your high blood pressure is not well controlled even with two blood pressure medications
  • Your blood sugar levels are not well controlled
  • You have a history of, or are currently suspected to have, a lung condition called interstitial lung disease (ILD)
  • You have a serious lung disease that significantly affects your breathing
  • You have a large build-up of fluid around your organs (such as around the lungs or abdomen) that is causing symptoms or is difficult to control
  • Scans suggest the tumour is pressing on or surrounding major blood vessels in the chest, neck, or throat area
  • You have had a serious blood clot event requiring treatment within the 6 months before joining (certain types of clots may be exempt — confirm with trial site)
  • You have active cancer that has spread to the brain or central nervous system
  • You have had an allergic reaction to similar medicines or to any ingredient in the study drug (BL-B01D1)
  • You have had an organ transplant or a stem cell transplant from a donor
  • You have HIV, active tuberculosis, active hepatitis B, or active hepatitis C
  • You have an active infection that requires treatment with medicines taken throughout the body
  • You have had significant bleeding or a strong tendency to bleed within the 4 weeks before signing the consent form
  • You have taken part in another clinical trial within 4 weeks before joining this one
  • The trial doctor feels there is any other reason you should not participate

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 27 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: Li Zhang, Sun Yat-Sen University Cancer Center

Phone: 15013238943

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
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
25 June 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR); Recommended Phase II Dose (RP2D)

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: 27 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