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NCT Number: NCT06465329

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)

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

The aim 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.

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)?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oncology Clinical Research Center, Cachoeiro de Itapemirim, Espírito Santo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Key Inclusion Criteria:

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

General Key Exclusion Criteria:

  • Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  • Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
  • Presence of grade≥ 2 peripheral neuropathy
  • Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

  • Grade ≥3 hypercalcemia, as defined in the protocol
  • Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  • 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

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

Treatment and study plan

cemiplimab

Drug

Intravenous (IV) infusion administration

Other names: REGN2810, LIBTAYO

Platinum-based Chemotherapy

Drug

IV infusion

REGN7075

Drug

IV infusion

Other names: EGFRxCD28 bispecific immunotherapy

Primary outcomes

  1. Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Pathologic complete response (pCR) rate as determined by central BIPR

    Time frame: Up to 12 weeks

  2. Residual viable tumor (RVT) as determined by central BIPR

    Time frame: Up to 12 weeks

  3. Median event-free survival (EFS)

    Time frame: Up to 5 years

  4. EFS rate

    Time frame: Up to 5 years

  5. Objective response rate (ORR)

    Time frame: Up to 9 weeks

  6. Overall survival (OS)

    Time frame: Up to 5 years

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 76 weeks

  8. Severity of TEAEs

    Time frame: Up to 76 weeks

  9. Incidence of TEAEs leading to death

    Time frame: Up to 76 weeks

  10. Incidence of TEAEs leading to treatment discontinuation

    Time frame: Up to 76 weeks

  11. Incidence of serious adverse events (SAEs)

    Time frame: Up to 76 weeks

  12. Incidence of adverse events of special interest (AESIs)

    Time frame: Up to 76 weeks

  13. Incidence of immune-mediated adverse events (imAEs)

    Time frame: Up to 76 weeks

  14. Incidence of infusion-related reactions (IRRs)

    Time frame: Up to 76 weeks

  15. Incidence of grade ≥3 laboratory abnormalities

    Time frame: Up to 76 weeks

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

  16. Proportion of delayed surgeries due to TEAEs

    Time frame: Up to 76 weeks

  17. Proportion of cancelled surgeries due to TEAEs

    Time frame: Up to 76 weeks

  18. Incidence of anti-drug antibodies (ADAs) to cemiplimab over time

    Time frame: Up to 67 weeks

  19. Titer of ADAs to cemiplimab over time

    Time frame: Up to 67 weeks

  20. Incidence of ADAs to novel anti-cancer agents over time

    Time frame: Up to 67 weeks

  21. Titer of ADAs to novel anti-cancer agents over time

    Time frame: Up to 67 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jun 18, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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