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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)

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 6 months later, primary endpoint(s) modified.

See at-risk trials from Regeneron

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Record History

All 17 versions: 17 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 20, 2027 to Dec 4, 2029 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 120 → 184 participants
    • Eligibility criteria expanded, about 223 words
    • Study completion pushed from May 2, 2030 to Dec 27, 2034
    • Interventions modified
    • Trial arms changed: 2 → 4
    • Secondary endpoints: 21 to 27
    • Site details revised at 1 of 47 sites
  2. Enrollment closed, study ongoing
    • Trial sites reduced: 50 → 47 locations
    v16
  3. Study sites: 49 to 50v15
  4. Study sites: 37 to 49v14
  5. Site details revised at 1 of 37 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 31 to 37v12
  2. Study sites: 30 to 31v11
  3. Eligibility criteria revisedv10 Show 4 more changesShow less
    • Study sites: 26 to 30
    • Primary completion date: Apr 15, 2027 to May 20, 2027
    • Study completion date: May 21, 2030 to May 2, 2030
    • Secondary endpoints: details revised at 3 of 21 entries
  4. Study sites: 19 to 26v9
  5. Study sites: 18 to 19v8
  6. Study sites: 13 to 18v7
  7. Study sites: 3 to 13v6
  8. Start date changed from estimate of Nov 15, 2024 to Nov 18, 2024v5
  9. Start date: Oct 15, 2024 to Nov 15, 2024v4
  10. Study sites: 1 to 3v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 15, 2024 to Oct 15, 2024
    • Study sites: 0 to 1
    • Primary completion date: Jun 22, 2027 to Apr 15, 2027
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
Timeframe: Up to 12 weeks
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 9 weeks
Occurrence of TEAEs leading to death
Timeframe: Up to 9 weeks
Occurrence of TEAEs leading to treatment discontinuation
Timeframe: Up to 9 weeks
Occurrence of Serious Adverse Events (SAEs)
Timeframe: Up to 9 weeks
Occurrence of grade ≥3 laboratory abnormalities
Timeframe: Up to 9 weeks
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
Timeframe: Up to 9 weeks

Secondary (27)

Pathologic Complete Response (pCR) rate as determined by central BIPR
Residual Viable Tumor (RVT) as determined by central BIPR
Event-Free Survival (EFS)
Objective Response by investigator assessment
Duration of Response (DoR) by investigator assessment
Show 22 moreShow less
Overall Survival (OS)
Occurrence of TEAEs
Severity of TEAEs
Occurrence of TEAEs leading to death
Occurrence of TEAEs leading to treatment discontinuation
Occurrence of SAEs
Severity of SAEs
Occurrence of Adverse Events of Special Interest (AESIs)
Severity of AESIs
Occurrence of immune-mediated Adverse Events (imAEs)
Severity of imAEs
Occurrence of Infusion-Related Reactions (IRRs)
Severity of IRRs
Occurrence of grade ≥3 laboratory abnormalities
Proportion of delayed surgeries due to TEAEs
Proportion of cancelled surgeries due to TEAEs
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
Magnitude of ADAs to cemiplimab
Occurrence of ADAs to marlotamig
Magnitude of ADAs to marlotamig
Occurrence of ADAs to REGN10597
Magnitude of ADAs to REGN10597

Arms and interventions

Neoadjuvant Resectable NSCLC - Control ArmActive comparator
Neoadjuvant Resectable NSCLC - Arm 1Experimental
Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2Experimental
Neoadjuvant Resectable NSCLC - Arm 2Experimental

Drugs: Cemiplimab, Platinum-based chemotherapy, Marlotamig, REGN10597

Sites

47 sites in 6 countries

Spain 12, United States 12, Brazil 11, France 7, Germany 4, Turkey (Türkiye) 1