A clinical study to assess the efficacy of adjuvant immunotherapy with cemiplimab in patients with surgically removed non-small cell lung cancer who have not received prior chemotherapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

ETOP IBCSG Partners Foundation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

17 Dec 2025 → ongoing

Decision date (initial)

2025-10-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Regeneron Pharmaceuticals, Inc.

External identifiers

EU CT number

2024-519901-36-00

ClinicalTrials.gov

NCT06931717

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients with resected stage II-IIIA NSCLC without prior adjuvant platinum-based chemotherapy, compared to observation without adjuvant treatment. The primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression of ≥1%.

Secondary objectives 2

1. To determine efficacy of adjuvant cemiplimab as measured by overall survival.
2. To assess tolerability and safety of adjuvant cemiplimab.

Conditions and MedDRA coding

Patients with resected stage II-IIIA non-small cell lung cancer (NSCLC) with PD-L1 expression ≥1%

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Resected pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC with negative surgical margins (R0). No disease recurrence following surgical resection.
2. Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.
3. Availability of archival FFPE tumour tissue for central PD-L1 expression testing.
4. Patient is not considered for adjuvant platinum-based chemotherapy due to a. Documented patient refusal; or b. Patient is unfit to receive adjuvant platinum-based chemotherapy (per investigator assessment) due to: ECOG PS2, or ECOG PS 0/1 and aged ≥70 years with substantial comorbidities or other contraindication(s) to platinum-based doublet chemotherapy
5. Estimated life expectancy of ≥3 months
6. Age ≥18 years
7. Patient has recovered from surgery-related complications
8. Adequate organ function
9. Negative pregnancy test for female participants of childbearing potential
10. Written Informed Consent before any trial-related intervention

Exclusion criteria 16

1. EGFR-mutant or ALK-rearranged NSCLC.
2. Any small cell component.
3. Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC.
4. Participating in another interventional clinical trial for NSCLC.
5. Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment.
6. Any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to randomisation.
7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
8. Encephalitis, meningitis, organic brain disease (e.g., Parkinson’s disease) or uncontrolled seizures within 1 year prior to randomisation.
9. Myocardial infarction within 6 months prior to randomisation.
10. Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation.
11. Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency.
12. Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation.
13. Receipt of a live vaccine within 28 days before randomisation.
14. Receipt of a COVID-19 vaccination within 1 week before randomisation.
15. Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation.
16. Known or suspected hypersensitivity to cemiplimab or its excipients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%)

Secondary endpoints 2

1. Overall survival
2. Incidence, nature and severity of adverse events according to CTCAE v5

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ETOP IBCSG Partners Foundation

Sponsor organisation

ETOP IBCSG Partners Foundation

Address

Effingerstrasse 33

City

Bern

Postcode

3008

Country

Switzerland

Scientific contact point

Organisation

ETOP IBCSG Partners Foundation

Contact name

ETOP IBCSG Partners Foundation Regulatory Office

Public contact point

Organisation

ETOP IBCSG Partners Foundation

Contact name

ETOP IBCSG Partners Foundation Regulatory Office

Third parties 4

Locations

7 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications