Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
novembre 2024
décembre 2034
04 novembre 2026
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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.