Phase 2 Lung Cancer Trial, Recruiting NCT06512051 Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06512051
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 who are able to understand and sign a consent form, and who are willing and able to follow the study schedule and requirements
  • People aged 18 to 70 years old, of any gender, at the time of signing the consent form
  • People who can provide a stored or freshly collected tumour tissue sample for testing
  • People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
  • People who have been confirmed by tissue or cell testing to have locally advanced or spread (metastatic) non-small cell lung cancer that cannot be treated with surgery, high-dose radiation therapy, or chemotherapy aimed at cure
  • People whose physical functioning is rated as 0 or 1 on a standard activity scale used by doctors (meaning fully active or able to carry out light activity)
  • People whose life expectancy is estimated to be at least 12 weeks
  • People whose liver, kidneys, and other organs are working at a good enough level (as assessed by the trial site)
  • People who agree to use a highly effective method of contraception during the study — this applies to men whose partners could become pregnant, and to women who are able to have children

Who may not be able to join:

  • People who have brain metastases (cancer that has spread to the brain) that are active or causing symptoms
  • People who have been diagnosed with another type of cancer, unless it was fully cleared at least 5 years ago and treatment has ended — certain skin cancers, early-stage bladder cancer, cervical cancer in situ, breast ductal cancer in situ, or papillary thyroid cancer with a clear record of cure may be exceptions (confirm with trial site)
  • People who have uncontrolled build-up of fluid around the lungs, abdomen, or heart
  • People whose cancer-related pain is not well controlled
  • People who received any cancer treatment within 4 weeks before starting the study
  • People who received higher-dose radiation therapy outside the chest within 28 days before starting, higher-dose radiation to the chest within 24 weeks before starting, or lower-dose radiation therapy within 14 days before starting (confirm with trial site)
  • People who are currently in another clinical trial, or whose last dose in a previous clinical trial was less than 4 weeks ago (or less than 5 half-lives of the study drug, whichever is longer)
  • People who had major surgery requiring general anaesthesia within 28 days before the study, minor or diagnostic surgery within 7 days before the study, or who are expected to need planned surgery during the trial
  • People whose side effects from previous cancer treatment have not sufficiently recovered (confirm with trial site)
  • People who received medicines to suppress the immune system within 14 days before starting the study
  • People who have a history of lung inflammation (interstitial or non-infectious pneumonia) that required steroid treatment, or who currently have or are suspected to have this condition
  • People who have any active, known, or suspected autoimmune disease (a condition where the immune system attacks the body)
  • People with serious heart or blood vessel (cardiovascular or cerebrovascular) conditions
  • People who had a severe infection within 28 days before starting the study
  • People with active hepatitis B or active hepatitis C
  • People who had active tuberculosis within 1 year before enrolling in the study
  • People who had significant bleeding or a high tendency to bleed within 1 month before starting the study
  • People with a history of immune deficiency
  • People who received a live vaccine within 28 days before starting the study, or who would need one during the study
  • Women who are pregnant or planning to become pregnant during the study
  • People with uncontrolled mental health conditions, or issues such as alcohol, drug, or substance misuse, or who are subject to criminal detention
  • People who the trial doctor determines have any other circumstances that could increase risk or interfere with the study
  • People with a bleeding tendency, high bleeding risk, blood clotting problems, or a tendency to form clots — this applies specifically to those receiving bevacizumab as part of the study
  • People with poorly controlled high blood pressure (systolic at or above 150 mmHg and/or diastolic at or above 100 mmHg despite treatment), or a history of hypertensive crisis or severe blood-pressure-related brain conditions — for those receiving bevacizumab
  • People who had a major blood vessel disease in the 6 months before starting — for those receiving bevacizumab
  • People who used full-dose blood-thinning or clot-dissolving medicines in the 7 days before starting (certain low-dose preventive uses may be allowed — confirm with trial site) — for those receiving bevacizumab
  • People who used or need to use certain blood-thinning medicines such as aspirin, clopidogrel, or similar platelet-inhibiting drugs within 7 days before starting — for those receiving bevacizumab
  • People with severe wounds that have not healed, active ulcers, or untreated broken bones — for those receiving bevacizumab
  • People who had a gastrointestinal perforation (a hole in the gut) in the 6 months before starting, or who show signs of bowel obstruction during screening — for those receiving bevacizumab
  • People whose scans show that the tumour is surrounding or growing into major blood vessels — for those receiving bevacizumab
  • People who have previously received systemic treatment with drugs that target blood vessel growth (such as bevacizumab, anlotinib, or similar medicines) — for those in the bevacizumab group

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 5 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

Phone: 0518-82342973

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
Shanghai Hengrui Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 July 2024
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

RP2D; Incidence and severity of AE(DLT); ORR

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: 5 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