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Cemiplimab-Rwlc

Phase 2

Non-small Cell Lung Cancer Stage III | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06449313Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node InvolvementPHASE2 RECRUITING 21Apr 1, 2026Sep 1, 2032Feb 12, 20263 United States
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Study Endpoints
Primary Endpoints
Pathologic complete response (pCR) rate
12 weeks

Pathologic complete response (pCR): 0% viable tumor in primary tumor and resected lymph nodes.

Secondary Endpoints
Objective Response Rate (ORR)
1 year
Rate of R0 Resection
12 weeks
Major pathologic response (MPR) rate
12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cemiplimab plus chemotherapyEXPERIMENTALcemiplimab given with standard of care chemotherapy for 4 treatments/cycles before surgery and then every 3 weeks for 1 year after surgery.
Interventions
NameTypeDescription
Cemiplimab-RwlcDRUG350 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06449313studyFirstPostDate: changed