Phase 3 Lung Cancer Trial, Recruiting NCT06096844 Sponsor: National Cancer Institute (NCI) Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT06096844
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:

  • People who are 70 years of age or older.
  • People who have been diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC), confirmed through a tissue or cell sample test.
  • People whose lung cancer has a specific marker called PD-L1, measured at a level between 1% and 49%.
  • People whose cancer is at an advanced stage (Stage IIIB, IIIC, or Stage IV) and for whom combined chemotherapy and radiation treatment is not suitable. People who previously had chemo-radiation for Stage III disease and whose cancer has come back may also be eligible.
  • People whose tumour does not have certain specific genetic changes (called EGFR or ALK mutations, or other similar changes) that would normally lead doctors to prescribe a different type of oral targeted treatment first.
  • People who have a specific level of physical functioning, rated as "2" on a standard medical scale, meaning they are limited in physical activity but able to care for themselves (confirm with trial site).
  • People who agree not to father children during the trial and for 6 months after the last treatment dose.
  • People who are able to understand and sign a consent form, or who have a legally authorised representative, caregiver, or family member who can do so on their behalf.
  • People whose recent blood test results (taken within the past 14 days) show that blood cell counts and organ function fall within the required ranges for white blood cells, platelets, red blood cells, liver function, and kidney function (confirm specific values with trial site).
  • People living with HIV who are on effective treatment and whose virus levels are undetectable within the past 6 months.
  • People with chronic hepatitis B whose virus levels are undetectable while on appropriate treatment.
  • People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated and have undetectable virus levels.
  • People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial (confirm with trial site).
  • People who speak English or Spanish (required for the quality-of-life part of the study, as forms cannot be translated).
  • People who have no active brain or spinal cord symptoms from cancer spread. People with a past history of cancer spread to the brain or spinal cord may be eligible if they have been treated, have been stable for at least 14 days before joining, and have not taken steroid medications for at least 24 hours beforehand.
  • People who have had baseline imaging (scans) of all cancer sites completed within the past 45 days.
  • People who have completed a baseline Geriatric Assessment (a health and wellbeing questionnaire for older adults) after registering for the first step of the trial.

Who may not be able to join:

  • People who have previously received chemotherapy treatment for cancer that has spread (metastatic disease). Chemotherapy given earlier for early-stage or locally advanced disease may be acceptable if treatment is finished and side effects have fully resolved.
  • People who have previously received immunotherapy treatment for cancer that has spread. Immunotherapy given earlier for early-stage or locally advanced disease may be acceptable if it was completed more than 6 months before joining the trial.
  • People who have an autoimmune condition that is not well controlled — though certain autoimmune conditions such as alopecia (hair loss), vitiligo, rheumatoid arthritis, psoriasis, a thyroid condition called Hashimoto's thyroiditis, lupus, or inflammatory bowel disease are permitted.
  • People who are currently taking immune-suppressing medications, including steroid medications at doses higher than a low daily threshold (equivalent to more than 10 mg of prednisone per day). Short courses of steroids that are stopped before the trial begins are acceptable. Steroids used through inhalers, nose sprays, or on the skin are permitted.
  • People who have active, symptomatic cancer spread to the brain or spinal cord that has not been treated or stabilised.

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 27 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

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Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 July 2024
Est. completion
31 January 2035

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Overall survival (OS)

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: 27 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