Printed from Voxsanity (voxsanity.com.au) — NCT06931717 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Lung Cancer Trial, Recruiting
NCT06931717
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- People diagnosed with stage II to IIIA non-small cell lung cancer (NSCLC), confirmed by laboratory testing, with brain imaging completed either before or after surgery (or at the screening stage if not yet done).
- People who have had their lung tumour fully removed by surgery, with no cancer cells found at the edges of the removed tissue (called a "clear margin").
- People whose surgery involved removal of a lobe, sleeve, two lobes, or the entire lung; or, for small tumours (2 cm or smaller), removal of a lung segment if a larger operation was not safe.
- People whose tumour tissue shows a PD-L1 protein level of 1% or higher, measured by an approved local laboratory test.
- People who have stored tumour tissue (called FFPE tissue) available for an additional central laboratory PD-L1 test.
- People who are not receiving standard post-surgery platinum-based chemotherapy — either because they have chosen not to have it, or because a doctor has assessed them as medically unsuitable for it (for example, due to having a lower physical performance level, being aged 70 or older with significant other health conditions, or having other reasons that make this chemotherapy unsafe).
- People with a life expectancy of at least 3 months.
- People aged 18 years or older.
- People who have recovered from any complications related to their lung surgery.
- People with adequate blood, kidney, and liver function as measured by laboratory tests.
- People who, in the doctor's assessment, are able to follow the trial procedures and requirements.
- Women who could become pregnant must have a negative blood pregnancy test within 5 weeks before joining the trial, repeated within 3 days before the first treatment dose and at every treatment visit.
- Women who could become pregnant and men whose partners could become pregnant must agree to use a highly effective form of contraception throughout treatment and for 4 months after the last dose of the trial drug (cemiplimab).
- People who have signed and dated a written consent form before any trial-related procedures begin.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose NSCLC has a specific gene change known as an EGFR mutation or ALK rearrangement.
- People whose lung cancer contains any small cell cancer component.
- People who have already received chemotherapy, immunotherapy, or other systemic treatments before or after surgery for their NSCLC.
- People currently taking part in another interventional clinical trial for NSCLC.
- People who have another cancer (other than NSCLC) that is still active or currently being treated — although certain exceptions may apply, such as non-melanoma skin cancer that has been treated, cervical cancer in situ, or other cancers considered to be definitively treated (confirm with trial site).
- People who need ongoing daily use of steroid medicines (above a certain dose) within 1 week before joining the trial, unless the steroids are for a routine hormone replacement purpose rather than to suppress the immune system. Inhaled or topical steroids are generally permitted if not used for an autoimmune condition.
- People with a significant autoimmune disease that has been treated with immune-suppressing medicines within the past 5 years — though certain mild conditions (such as vitiligo, thyroid conditions managed with hormone replacement, or type 1 diabetes) are generally not excluded.
- People who have had brain inflammation (encephalitis or meningitis), an organic brain disease such as Parkinson's disease, or uncontrolled seizures within the past year.
- People who have had a heart attack within the past 6 months.
- People with a known history of, or current, interstitial lung disease or non-infectious lung inflammation within the past 5 years.
- People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a known immune deficiency condition — though people with well-controlled versions of these infections (meeting specific laboratory criteria) may be eligible (confirm with trial site).
- People who have had an infection serious enough to require hospital admission or intravenous antibiotics within 2 weeks before joining the trial.
- People who have received a live vaccine within 28 days before joining the trial.
- People who have received a COVID-19 vaccine within 1 week before joining the trial.
- People who have previously had an organ transplant or allogeneic stem cell transplant at any time, or an autologous stem cell transplant within the past 12 weeks.
- People with a known or suspected allergic reaction to the trial drug cemiplimab or any of its ingredients.
- Women who are pregnant, planning to become pregnant, or currently breastfeeding.
- Sexually active people who could become pregnant (or whose partner could become pregnant) and who are not willing to use effective contraception during the trial.
- People who are themselves a member of the clinical study team, or who have an immediate family member on the study team, unless the trial sponsor has given prior approval.
- People the investigator believes are unlikely to follow the trial's procedures and requirements.
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.
Contact this trial
Principal Investigator: Ross Soo, MB BS, PhD, FRACP, National University Hospital, Singapore
Phone: +41 31 511 94 00
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 3
Sponsor
ETOP IBCSG Partners Foundation
Registry
ClinicalTrials.gov
Start date
12 January 2026
Est. completion
1 March 2029
Where this trial is recruiting
🇦🇹 Austria
🇪🇪 Estonia
🇫🇷 France
🇩🇪 Germany
🇮🇪 Ireland
🇮🇹 Italy
🇸🇬 Singapore
🇪🇸 Spain
🇨🇭 Switzerland
Primary endpoints
Disease-free survival (DFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.