Phase 2 Lung Cancer Trial, Recruiting NCT07089199 Sponsor: Qilu Hospital of Shandong University Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT07089199
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:

  • Adults between 18 and 75 years old (any gender)
  • People who have been confirmed through tissue testing to have Stage III non-small cell lung cancer (using the AJCC 8th edition staging system)
  • People whose surgeon has assessed the tumor as removable by surgery
  • People whose cancer tests negative or has unknown results for certain gene changes called EGFR and ALK mutations (unknown results are only acceptable for a type called squamous non-small cell lung cancer)
  • People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (ECOG), meaning fully active or able to carry out light activity
  • People who have not received any previous treatment for their lung cancer
  • People who have at least one measurable tumor area on scans, as defined by standard measurement guidelines (RECIST v1.1)
  • People who are able to read, understand, and sign a consent form agreeing to the study requirements and schedule
  • People whose blood, kidney, and liver function meet specific healthy levels, without having needed a blood transfusion or certain blood-boosting medications in the 14 days before testing (confirm specific values with trial site)
  • Women who could become pregnant must have a negative blood pregnancy test within 3 days before the first dose; both women of childbearing age and men whose partners could become pregnant must agree to use highly effective contraception during the study and for 120 days after the last dose

Who may not be able to join:

  • People who have already received any treatment for their current lung cancer, including radiation, chemotherapy, immunotherapy, targeted therapy, or anti-blood-vessel therapy
  • People whose cancer has a known gene change such as EGFR mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, or similar (this does not apply to people with squamous non-small cell lung cancer where EGFR and ALK status is unknown)
  • People who have difficulty taking oral medications, such as those who cannot swallow, have ongoing diarrhea, or have a bowel blockage
  • People with a known allergy to any of the study drugs (Tislelizumab, Anlotinib, or albumin-bound Paclitaxel) or their ingredients
  • People whose scans show the tumor has grown into major blood vessels, or where the treating doctor believes treatment could cause life-threatening bleeding
  • People who have coughed up significant amounts of blood (more than 50 ml per day) in the 3 months before the study, or who have signs of significant bleeding from other sources such as the stomach or bowel
  • People who have received a live attenuated vaccine within 4 weeks before the first dose, or who plan to receive one during the study
  • People who are not expected to be able to tolerate surgery, such as those with significant heart or lung insufficiency
  • People who have had another cancer in the past 5 years, except for certain fully treated early-stage cancers including cervical carcinoma in situ, non-melanoma skin cancer, or certain superficial bladder tumours
  • People with active viral hepatitis that the treating doctor determines requires treatment
  • People with active autoimmune diseases requiring ongoing treatment throughout the body, or who require long-term high-dose steroids or other immune-modifying medications in a way the doctor believes would affect the study treatment
  • People with unhealed surgical wounds before starting the study (small biopsy wounds may be acceptable)
  • People with active Hepatitis B, Hepatitis C, or HIV infection
  • People who have had a blood clot or serious cardiovascular event in the past 6 months, such as a stroke, deep vein thrombosis, or pulmonary embolism, or who have significant heart conditions such as uncontrolled abnormal heart rhythms, significant heart failure, or reduced heart pumping function
  • People with interstitial lung disease or uncontrolled ongoing medical conditions such as diabetes, high blood pressure, or acute lung disease
  • People with active bleeding, blood clotting problems, or who are currently receiving blood-thinning or clot-dissolving medications; also people who have had major surgery requiring general anaesthesia within 28 days before the first dose
  • People with underlying health conditions, or alcohol or drug misuse, that could make the study drugs unsafe or make the results difficult to interpret

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 8 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: 18560081902

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
Qilu Hospital of Shandong University
Registry
ClinicalTrials.gov
Start date
25 July 2025
Est. completion
10 July 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

pathological complete response (pCR)

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: 8 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