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)
Public ClinicalTrials.gov record NCT06465329. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. 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
Study identification
- NCT ID
- NCT06465329
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2024 (Actual)
- Primary completion
- Dec 4, 2029 (Estimated)
- Completion
- Dec 27, 2034 (Estimated)
- Last update posted
- Nov 3, 2026
2024 – 2034
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | — |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | — |
| Oncology Hematology Care Clinical Trials LLC | Cincinnati | Ohio | 45245 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| University Of Nebraska Medical Center | Portland | Oregon | 97213 | — |
| Lifespan Cancer Institute | Providence | Rhode Island | 02903 | — |
| Prairie Lakes Healthcare System | Watertown | South Dakota | 57201 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Sarah Cannon Research Institute (SCRI) Oncology Partners | Nashville | Tennessee | 37203 | — |
| BRCC/Oncology & Hematology Associates of SW Virginia | Blacksburg | Virginia | 24060 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06465329, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06465329 live on ClinicalTrials.gov.