Phase 3 Lung Cancer Trial, Not Yet Recruiting NCT06847334 Sponsor: Shanghai Henlius Biotech Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Not Yet Recruiting

NCT06847334
Not Yet Recruiting Phase 3

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 have been confirmed by a lab test to have stage IV non-squamous non-small cell lung cancer (a specific type of advanced lung cancer) that cannot be treated with surgery or radiation.
  • Your cancer does not have certain specific genetic changes known as EGFR mutations, or ALK or ROS1 gene rearrangements.
  • You have not yet received any systemic treatment (such as chemotherapy or immunotherapy) for your advanced or metastatic lung cancer.
  • You have at least one measurable tumor that can be tracked on scans.
  • You are in reasonably good general health, able to carry out daily activities with little or no limitation (confirm with trial site).
  • Your major organs (such as liver, kidneys, and bone marrow) are functioning well enough as shown by blood tests.

Who may not be able to join:

  • You have a mixed or different type of lung cancer, small cell lung cancer, or a related type called neuroendocrine carcinoma.
  • You have had another active cancer in the past 5 years or currently have another cancer at the same time.
  • Your lung cancer has spread to the brain or spinal cord and is currently causing active symptoms.
  • You have known serious lung conditions such as interstitial lung disease, dust-related lung disease, radiation damage to the lungs, or drug-related lung inflammation.
  • You have a known active or suspected condition where your immune system attacks your own body (such as lupus or rheumatoid arthritis).
  • You have a weakened immune system, are HIV positive, or have active hepatitis B or hepatitis C infection.
  • You have previously been treated with pembrolizumab or similar immunotherapy drugs that target PD-1, PD-L1, or CTLA-4.
  • You are currently pregnant or breastfeeding.
  • The doctor running the trial has a specific reason to believe joining this study could be harmful to you.

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 28 July 2026
Phase 3: approximately ~65% 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

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Shanghai Henlius Biotech
Registry
ClinicalTrials.gov
Start date
27 April 2025
Est. completion
9 April 2027

Primary endpoints

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d); Area under the serum concentration-time curve within a dosing interval at steady state (AUCss); Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1

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: 28 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