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Non Small Cell Lung CancerPhase 2RADICAL-IONCT07808138

RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer

A Phase 2 study testing Cemiplimab 350 mg IV in people with Non Small Cell Lung Cancer and Immunotherapy, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy. In this study, patients with a high chance to respond to immunotherapy will be selected. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Immunotherapy
What is being tested?
Cemiplimab 350 mg IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesNetherlands
Study dates
Nov 2026to 1 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have pathologically proven newly diagnosed, treatment-naive stage IA (i.e. tumor diameter ≤ 3 cm) NSCLC according to the 9th AJCC/UICC staging classification (30).
  • Be willing and able to provide written informed consent/assent for the trial.
  • Be 18 years of age on day of signing informed consent.
  • Should have measurable disease according to RECIST 1.1.
  • Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
  • Molecular analysis using next-generation sequencing (NGS) should be performed to identify oncogenic driver alterations and/or STK11 or KEAP1 mutations. If NGS is not available, the patient must have a smoking history of at least 10 packyears.
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  • PD-L1 TPS should be at least 50%.
  • Should have an indication for SABR determined by the multidisciplinary team meeting.
  • Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 14 days of treatment initiation.
  • Female participant of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the 1st dose of study medication.

Who cannot join

  • Has a known driver mutation associated with lack of cemiplimab efficacy (e.g. EGFR, ALK, HER2, RET or ROS1). Patients with smoking-related targetable driver mutation (e.g. KRAS or BRAF non-V600E) are eligible for this study. If this is unavailable, a patient should have smoked ≥10 packyears to be eligible.
  • Has a known mutation in STK11 and/or KEAP1 predictive of poor response to PD-(L)1 inhibitors.
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the 1st dose of treatment.
  • Has received prior therapy with any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways other than PD-(L)1 blockade, e.g. anti-CD137 or a CTLA-4 antibody.
  • Has a known additional malignancy that is progressing or requires active treatment.
  • Has evidence of symptomatic interstitial lung disease or an active, non-infectious pneumonitis.
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  • Presence of cardiovascular disease, as defined by:
  • New York Heart Association heart failure classifications of Class II, III or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication or
  • Transient ischemic attack or stroke within 1 year
  • Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
  • Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
  • Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
  • Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication.
  • Uncontrolled infection with known HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
  • Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are eligible. For these participants monitoring will be performed per local standards.
  • Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study medication.
  • Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.
  • Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to successful prior course of anti-HCV therapy) are eligible.
  • Receipt of a live vaccine within 4 weeks of start of study medication
  • Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication
  • Known hypersensitivity to the active substances or to any of the excipients.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to first dose.
  • Is currently breastfeeding or intends to breastfeed during the study period.
  • WOCBP* or men** who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study and for at least 4 months after the last dose. Highly effective contraceptive measures include:
  • Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
  • Intrauterine device; intrauterine hormone-releasing system;
  • Bilateral tubal occlusion/ligation;
  • Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
  • Sexual abstinence †,‡

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. W.S.M.E. Theelen, MD PhD contact

0031 020 512 9111.

w.theelen@nki.nl

Eline R Harding, MD contact

0031 020 512 9111.

e.harding@NKI.nl

Netherlands2 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

    Dr. W.S.M.E Theelen, MD PhD, 0031 020 512 9111., w.theelen@nki.nl

    Eline R Harding, MD, 0031 020 512 9111., e.harding@NKI.nl

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA

    Lydia Schonewille, MD, 0031 071 526 9111, l.h.n.schonewille@lumc.nl

Other trials in Netherlands

About this study

Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy. In this study, patients with a high chance to respond to immunotherapy will be selected. These patients will be treated with immunotherapy alone, thereby evaluating whether these patients can be cured without surgery or radiotherapy.

Read the detailed description

Early-stage non-small cell lung cancer (NSCLC) patients with a pathological complete response (pCR) to neoadjuvant chemoimmunotherapy are potentially already cured before the local radical treatment is administered. However, treatment de-escalation in these patients is unfeasible since pCR detection before local radical treatment is unreliable. The investigators propose to evaluate if local radical therapy can be omitted after immunotherapy in selected participants with stage Ia NSCLC with high probability of immunotherapy benefit.

Participants receive three cycles of 350 milligrams of cemiplimab intravenously every three weeks followed by a radiological and metabolic response evaluation with respectively CT and [18F]FDG-PET. Thereafter participants will enter the follow-up phase where response will be closely monitored with CT scans 3-monthly. Additionally, blood will be collected for ctDNA analysis at baseline, during treatment with cemiplimab and follow-up will be collected. According to standard of care, participants will undergo a [18F]FDG-PET scan if progressive disease is suspected. Participants with disease recurrence will be treated off-study at the discretion of the treating physician.

Being tested
Cemiplimab 350 mg IV
Keywords
early stage non small cell lung cancer, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cemiplimab 350 mg IVDrug

    Also called Libtayo

    three cycles of 350 milligrams of cemiplimab intravenously every three weeks

Study groups in NCT07808138
Study groupRoleWhat they receive
Three cycles of cemiplimabActive comparatorThree cycles of cemiplimab
Receives: Drug: Cemiplimab 350 mg IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence free survival (RFS) as per RECIST 1.1

    Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1, fatal TRAEs or NSCLC-related death.

    Measured: 24 months

Secondary outcomes (7)

  1. Estimate event free survival

    Time from first cemiplimab administration to disease recurrence/progression as per RECIST 1.1 or death of any cause

    Measured: 24 months

  2. Evaluate safety

    Grade >3 TRAEs classified by NCI-CTCAE v5 up until 90 days after the last cemiplimab cycle, in particular pneumonitis. Rate of local radical therapy after disease recurrence.

    Measured: 24 months

  3. Estimate survival

    Overall survival (time from first cemiplimab administration to death of any cause) and disease specific survival (time from first cemiplimab administration to NSCLC related death)

    Measured: 24 months

  4. Estimate location of disease recurrence

    Time from first cemiplimab administration to local, regional and distant disease recurrence/progression

    Measured: 24 months

  5. Objective response rate (ORR)

    Objective response rate as per RECIST 1.1

    Measured: 24 months

  6. BoR

    Best objective response rate as per RECIST 1.1

    Measured: 24 months

  7. DoR

    Time between objective response to disease recurrence as per RECIST 1.1

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study startNov 2026 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07808138
Sponsor's protocol ID
M25RIO
Other IDs
2025-524305-32-00, 2025
Acronym
RADICAL-IO
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab 350 mg IV in people with Non Small Cell Lung Cancer and Immunotherapy, run by The Netherlands Cancer Institute at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. W.S.M.E. Theelen, MD PhD (0031 020 512 9111., w.theelen@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (RFS) as per RECIST 1.1 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07808138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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