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Non Small Cell Lung CancerPhase 2NCT06465329

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Cemiplimab, Platinum-based chemotherapy and Marlotamig in people with Non Small Cell Lung Cancer and NSCLC, run by Regeneron Pharmaceuticals at 47 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion. The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, NSCLC
What is being tested?
Cemiplimab, Platinum-based chemotherapy and Marlotamig
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
47 sitesin 6 countries
Study dates
18 Nov 2024to 27 Dec 2034
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

Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. Adequate organ and bone marrow function, as described in the protocol

Arm Specific Inclusion Criteria:

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
  2. Availability of an archival or on-trial FFPE tumor tissue sample
  3. ECOG performance status of 0 or 1
  4. Per investigator judgment, life expectancy of at least 3 months

Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
  3. Presence of grade≥ 2 peripheral neuropathy
  4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Neoadjuvant Resectable NSCLC - Arm 1:

  1. Grade ≥3 hypercalcemia, as defined in the protocol
  2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
  3. Known allergy or hypersensitivity to any components of trial interventions
  4. Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol

Neoadjuvant Resectable NSCLC - Arm 2:

  1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

47 sites in 6 countries.

47 sites in 6 countries

United States12 sites

  • BRCC/Oncology & Hematology Associates of SW Virginia

    Blacksburg, Virginia, 24060

  • Oncology Hematology Care Clinical Trials LLC

    Cincinnati, Ohio, 45245

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    Nashville, Tennessee, 37203

  • University of California Irvine

    Orange, California, 92868

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • University Of Nebraska Medical Center

    Portland, Oregon, 97213

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57201

Other trials in United States

Spain12 sites

  • Catalan Instituye of Oncology Badalona

    Badalona, Barcelona, 08916

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Valdecilla

    Santander, Cantabria, 39008

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario Valencia

    Valencia, 46010

  • Consorci Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Clinico Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Brazil11 sites

  • Instituto Mario Penna

    Belo Horizonte, Minas Gerais, 30380-472

  • Oncology Clinical Research Center

    Cachoeiro de Itapemirim, Espírito Santo, 29306014

  • Ynova Pesquisa Clinica

    Florianópolis, Santa Catarina, 88020-210

  • Liga Norte Riograndense Contra o Cancer

    Natal, Rio Grande do Norte, 59060-195

  • Hospital Mae de Deus Integrated Oncology Center

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Sul Mineiro De Oncologia LTDA

    Pouso Alegre, Minas Gerais, 37554-238

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco, 50070-902

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903

  • Unimed Sorocaba

    Sorocaba, São Paulo, 18065-100

Other trials in Brazil

France7 sites

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • Clinique Belharra

    Bayonne, 64100

  • CHU Grenoble Alpes

    Grenoble, 38330

  • Montpellier Academic Hospital

    Montpellier, 34295

  • Institut Curie

    Paris, Île-de-France Region, 75005

  • CHU Rennes

    Rennes, Brittany Region, 35033

  • Centre Hospitalier Intercommunal Toulon - CHITS

    Toulon, Var, 83055

Other trials in France

Germany4 sites

  • University Hospital RWTH Aachen

    Aachen, 52074

  • University Medicine Gottingen

    Göttingen, Lower Saxony, 37083

  • Klinikum Kassel GmbH, Hauttumorzentrum

    Kassel, Hesse, 34125

  • University of Leipzig

    Leipzig, Saxony, 04103

Other trials in Germany

Turkey (Türkiye)1 site

  • Florya Medical Park Hospital

    Istanbul, 34295

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.

The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

Read more

For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."

The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.

For the resectable NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the investigational treatments in comparison to the control treatment
  • Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
  • How much of the study drug(s) are in the blood at a given time
  • Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
  • How does the additional drug work in combination with cemiplimab and chemotherapy
Being tested
Cemiplimab, Platinum-based chemotherapy, Marlotamig, REGN10597
Keywords
Carcinoma, Non-Small Cell Lung, Early stage lung cancer, Early-stage non-small cell lung cancer, Lung cancer surgery, Lung Carcinoma, Neoadjuvant NSCLC, Non-small cell lung carcinoma, NSCLC, Operable non-small cell lung cancer, Preoperative NSCLC, Resectable NSCLC, Surgical resection
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • CemiplimabDrug

    Also called REGN2810, LIBTAYO

    Administered per the protocol

  • Platinum-based chemotherapyDrug

    Administered per the protocol

  • MarlotamigDrug

    Also called REGN7075

    Administered per the protocol

  • REGN10597Drug

    Also called PD-1-IL2Ra-IL2 immunotherapy

    Administered per the protocol

Study groups in NCT06465329
Study groupRoleWhat they receive
Neoadjuvant Resectable NSCLC - Control ArmActive comparatorNot described
Receives: Drug: Cemiplimab; Drug: Platinum-based chemotherapy
Neoadjuvant Resectable NSCLC - Arm 1ExperimentalNot described
Receives: Drug: Cemiplimab; Drug: Platinum-based chemotherapy; Drug: Marlotamig
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2ExperimentalNot described
Receives: Drug: Cemiplimab; Drug: Platinum-based chemotherapy; Drug: REGN10597
Neoadjuvant Resectable NSCLC - Arm 2ExperimentalNot described
Receives: Drug: Cemiplimab; Drug: Platinum-based chemotherapy; Drug: REGN10597

What is being measured

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

  1. Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)

    Measured: Up to 12 weeks

  2. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 9 weeks

  3. Occurrence of TEAEs leading to death

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 9 weeks

  4. Occurrence of TEAEs leading to treatment discontinuation

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 9 weeks

  5. Occurrence of Serious Adverse Events (SAEs)

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 9 weeks

  6. Occurrence of grade ≥3 laboratory abnormalities

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)

    Measured: Up to 9 weeks

  7. Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 9 weeks

Secondary outcomes (27)

  1. Pathologic Complete Response (pCR) rate as determined by central BIPR

    Measured: Up to 12 weeks

  2. Residual Viable Tumor (RVT) as determined by central BIPR

    Measured: Up to 12 weeks

  3. Event-Free Survival (EFS)

    Measured: Up to 5 years

  4. Objective Response by investigator assessment

    Measured: Up to 9 weeks

  5. Duration of Response (DoR) by investigator assessment

    Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

    Measured: Up to 2 years

  6. Overall Survival (OS)

    Measured: Up to 5 years

  7. Occurrence of TEAEs

    Measured: Up to 76 weeks

  8. Severity of TEAEs

    Measured: Up to 76 weeks

  9. Occurrence of TEAEs leading to death

    Measured: Up to 76 weeks

  10. Occurrence of TEAEs leading to treatment discontinuation

    Measured: Up to 76 weeks

  11. Occurrence of SAEs

    Measured: Up to 76 weeks

  12. Severity of SAEs

    Measured: Up to 76 weeks

  13. Occurrence of Adverse Events of Special Interest (AESIs)

    Measured: Up to 76 weeks

  14. Severity of AESIs

    Measured: Up to 76 weeks

  15. Occurrence of immune-mediated Adverse Events (imAEs)

    Measured: Up to 76 weeks

  16. Severity of imAEs

    Measured: Up to 76 weeks

  17. Occurrence of Infusion-Related Reactions (IRRs)

    Measured: Up to 76 weeks

  18. Severity of IRRs

    Measured: Up to 76 weeks

  19. Occurrence of grade ≥3 laboratory abnormalities

    As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)

    Measured: Up to 76 weeks

  20. Proportion of delayed surgeries due to TEAEs

    Measured: Up to 76 weeks

  21. Proportion of cancelled surgeries due to TEAEs

    Measured: Up to 76 weeks

  22. Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab

    Measured: Up to 67 weeks

  23. Magnitude of ADAs to cemiplimab

    Measured: Up to 67 weeks

  24. Occurrence of ADAs to marlotamig

    Measured: Up to 67 weeks

  25. Magnitude of ADAs to marlotamig

    Measured: Up to 67 weeks

  26. Occurrence of ADAs to REGN10597

    Measured: Up to 67 weeks

  27. Magnitude of ADAs to REGN10597

    Measured: Up to 67 weeks

Timeline

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

  1. First posted18 Jun 2024
  2. Study start18 Nov 2024
  3. Primary completion4 Dec 2029 (estimated)
  4. Study completion27 Dec 2034 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06465329
Sponsor's protocol ID
R2810-ONC-2268
Other IDs
2023-509806-31-00, 2023
Status last verified
Oct 2026
First submitted
13 Jun 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab, Platinum-based chemotherapy and Marlotamig in people with Non Small Cell Lung Cancer and NSCLC, run by Regeneron Pharmaceuticals at 47 sites in 6 countries.

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

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Spain, Brazil, France, Germany and 1 more country. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR) (time frame: Up to 12 weeks). The study lists 7 primary outcomes in all. 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 NCT06465329.

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 3 Nov 2026.

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