Approval Probability
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Cemiplimab-Rwlc · 1 trial · 1 indication
Pathologic complete response (pCR): 0% viable tumor in primary tumor and resected lymph nodes.
| Arm | Type | Description |
|---|---|---|
| Cemiplimab plus chemotherapy | EXPERIMENTAL | cemiplimab given with standard of care chemotherapy for 4 treatments/cycles before surgery and then every 3 weeks for 1 year after surgery. |
| Name | Type | Description |
|---|---|---|
| Cemiplimab-Rwlc | DRUG | 350 mg every 3 weeks, intravenously, on day 1 of a 21 day cycle for 4 cycles, then every 3 weeks after surgery for 1 year. |
Inclusion Criteria: 1. Age ≥ 18 years at time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed stage 3 B/C Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) with pathologically-confirmed contralateral mediast...
Cemiplimab-Rwlc is being studied for the treatment of Non-small Cell Lung Cancer Stage III, specifically in a neoadjuvant setting. It is administered as part of a chemo-immunotherapy regimen before surgical resection in patients with locally advanced disease and N3 lymph node involvement. The drug is currently in Phase 2 clinical development.
Cemiplimab-Rwlc targets the PD-1 receptor, a protein on immune cells that tumors can exploit to evade detection. By blocking PD-1, the drug helps the immune system recognize and attack cancer cells. This mechanism is being evaluated in the context of non-small cell lung cancer, where it is combined with chemotherapy before surgery.
Cemiplimab-Rwlc is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with stage III non-small cell lung cancer.
Cemiplimab-Rwlc is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing trial is recruiting patients with Non-small Cell Lung Cancer Stage III to assess the safety and efficacy of the neoadjuvant chemo-immunotherapy approach.
Cemiplimab-Rwlc is being evaluated in a single Phase 2 clinical trial with the identifier NCT06449313. This trial, titled 'Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement,' is recruiting 21 participants in the United States. The study is uncontrolled and not blinded.
Cemiplimab-Rwlc is the generic name for the drug marketed as Libtayo. However, in the context of this specific clinical trial, the drug is being tested as a neoadjuvant treatment for stage III non-small cell lung cancer. The trial is sponsored by Regeneron Pharmaceuticals and is currently in Phase 2 development.