Phase 2 Lung Cancer Trial, Recruiting NCT05351788 Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05351788
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 at the time of signing the consent form
  • People who have been confirmed through laboratory testing (biopsy or cell samples) to have non-small cell lung cancer (NSCLC)
  • People who fit into one of three groups: (1) advanced or metastatic NSCLC without certain genetic changes (EGFR wild-type and ALK-negative), with no more than one prior round of chemotherapy for advanced disease; (2) advanced or metastatic NSCLC without those same genetic changes and no prior treatment at all; or (3) advanced or metastatic NSCLC with a specific genetic change (EGFR activating mutation) but no ALK gene change, where previous targeted therapy (EGFR-TKI) has stopped working
  • People who are able to provide a fresh or previously collected tumour tissue sample for testing
  • People who have at least one measurable tumour that can be tracked on scans, and whose cancer is not only in the skin or bones
  • People who are relatively well and active in daily life (rated 0 or 1 on a standard health scale used in cancer trials), with an expected survival of at least 12 weeks
  • People whose blood tests show their organs and bone marrow are functioning well enough (confirm with trial site for specific thresholds)
  • People of childbearing potential (both female and male) who agree to use effective contraception during the treatment period and for 6 months after the last dose
  • People who voluntarily agree to take part, sign the consent form, and attend all required visits and procedures

Who may not be able to join:

  • People whose lung cancer contains small cell lung cancer (SCLC) components
  • People with a history of other cancers
  • People who have cancer that has spread to the brainstem, the lining of the brain or spinal cord, or who have spinal cord compression
  • People with currently active cancer spread to the brain or central nervous system
  • People whose tumour, on CT or MRI scans, is wrapped around or very close to major blood vessels in a way that raises concern about serious bleeding risk
  • People with serious or uncontrolled heart disease or significant heart-related symptoms requiring treatment (confirm with trial site for specific heart conditions listed)
  • People with a non-infectious lung condition called interstitial lung disease (ILD), a history of lung inflammation that required steroid treatment, or serious loss of lung function due to existing lung disease
  • People with uncontrolled ongoing health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, or significant fluid build-up around the lungs, heart, or in the abdomen
  • People with active hepatitis B or hepatitis C infection, known HIV infection or AIDS, or a positive syphilis antibody test
  • People with known active tuberculosis
  • People with a known allergy or serious reaction to the study drug or its ingredients, or a history of severe allergic reactions to similar medications (monoclonal antibodies)
  • People who have previously received an organ transplant or a stem cell transplant from a donor
  • People who are pregnant or currently breastfeeding
  • People whose condition worsens significantly during the screening period before receiving the first dose, such as a rapid decline in general health or pain that requires changes to pain medication
  • People who, in the trial doctor's judgement, have any other condition that makes participation 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 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

Phone: 028-67255165

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 Kelun-Biotech Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
20 May 2022
Est. completion
1 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence and severity of adverse events (AEs); Objective Response Rate (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: 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