Phase 2 Lung Cancer Trial, Recruiting NCT06102057 Sponsor: TheraOp Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06102057
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 18 years of age or older
  • You have been diagnosed with non-small cell lung cancer (NSCLC) that is at an advanced local stage (Stage III) and cannot be removed by surgery, confirmed by a tissue or cell sample
  • Your cancer shows a certain protein marker (PD-L1) present in at least 1% of tumor cells, confirmed by a standard lab test
  • Doctors have agreed, as a team, that you are suitable for combined chemotherapy with radiation followed by immunotherapy
  • You are generally in good physical health and able to carry out daily activities with little to no limitation (based on a standard doctor's rating scale of 0 or 1)
  • You have had a specific type of full-body scan (FDG-PET CT) within the last 21 days before starting treatment
  • Your lung function tests meet the minimum required levels (confirm with trial site for exact values)
  • Your blood counts, liver function, and kidney function are all within acceptable ranges (confirm with trial site for exact values)
  • You weigh more than 30 kg
  • If you are a woman who could become pregnant, you have had a negative pregnancy test before joining
  • You agree to use highly effective contraception throughout the treatment and for at least 90 days after the last immunotherapy dose or 6 months after the last chemotherapy dose, whichever is later (applies to both women who could become pregnant and men whose partners could become pregnant)
  • You are willing and able to attend all scheduled visits and follow the study requirements
  • You have given written consent to take part

Who may not be able to join:

  • Your lung cancer is a mixed type involving small cell lung cancer, or is a neuroendocrine tumor
  • Your cancer has spread to other parts of the body (distant metastases)
  • You have fluid around your lungs or heart caused by cancer
  • You have a blockage of a major vein in your chest (superior vena cava obstruction)
  • You have previously had treatment for this NSCLC, such as surgery, radiotherapy, chemotherapy, or immunotherapy (a limited exception may apply for early-stage NSCLC treated in the past — confirm with trial site)
  • You have received a live vaccine within the 30 days before starting treatment
  • You have had a major surgical procedure within 28 days before starting treatment
  • You have previously received immunotherapy drugs such as checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 treatments, or cancer vaccines)
  • You are currently taking strong immune-suppressing medications on a long-term basis (some exceptions, such as low-dose steroids or inhaled/topical steroids, may apply — confirm with trial site)
  • You have previously had an organ transplant from another person
  • You have an active or past autoimmune or inflammatory condition such as lupus, Crohn's disease, rheumatoid arthritis, or similar disorders (some exceptions may apply — confirm with trial site)
  • You have another serious illness that is not well controlled, such as an active infection, heart failure, uncontrolled high blood pressure, or a serious mental health condition
  • You require oxygen to breathe
  • You have active swollen lymph nodes in your chest related to certain lung conditions such as silicosis, sarcoidosis, or tuberculosis
  • You have or have had another type of cancer within the past 2 years (some exceptions for certain skin cancers or early-stage cancers fully treated more than 2 years ago may apply — confirm with trial site)
  • You have a history of cancer spreading to the lining around the brain or spinal cord
  • You have tested positive for hepatitis B, hepatitis C, tuberculosis, or HIV
  • You have a known allergy to any of the study medications, including durvalumab or the chemotherapy drugs used in this trial
  • You have a type of lung tumor (such as Pancoast or superior sulcus tumors) that doctors are planning to treat with surgery
  • You are currently enrolled in another clinical trial involving an experimental treatment
  • You have taken part in another clinical trial with an experimental drug within the 4 weeks before joining this study
  • You are pregnant or breastfeeding

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

Principal Investigator: Ursula Nestle, Prof., Kliniken Maria Hilf GmbH

Phone: +49 641 944 36 36

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
TheraOp
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇩🇪 Germany 🇨🇭 Switzerland

Primary endpoints

Comparison of the Completion rate of Experimental Arm to Conventional Arm

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