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NCT06918132 · ClinicalTrials.gov registry record · Phase 2

Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer

A Phase 2 study of Lung Non-Small Cell Carcinoma and Stage IIIB Lung Cancer AJCC v8, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06918132: Recruiting Phase 2 study of Lung Non-Small Cell Carcinoma and Stage IIIB Lung Cancer AJCC v8, sponsored by Mayo Clinic.

NCT06918132 is a Phase 2 study of Lung Non-Small Cell Carcinoma and Stage IIIB Lung Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 60 participants, below the 159-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06918132, a Phase 2 study of Lung Non-Small Cell Carcinoma and Stage IIIB Lung Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.

Primary Outcome

Will be defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. Will be conducted using two parallel Simon two-stage trial designs. Will be evaluated within the PD-L1 1-49% group.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Cemiplimab
  • PROCEDURE Surgical Procedure
  • BIOLOGICAL Fianlimab

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-04-29
Est. Completion 2027-04-29
Phase Phase 2
Mayo Clinic

2,844 total trials

What NCT06918132 shows while recruiting

NCT06918132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 159-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (62% lower).

The record links to 5 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06918132 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT06918132 about?

NCT06918132 is a clinical study titled "Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer". This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before g...

What is the current status of trial NCT06918132?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-04-29. Estimated completion is 2027-04-29.

What conditions does trial NCT06918132 study?

This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8.

What interventions are being tested in trial NCT06918132?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cemiplimab (BIOLOGICAL), Surgical Procedure (PROCEDURE), Fianlimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06918132?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06918132 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Lung Non-Small Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06918132's enrollment target sits among peer trials

60 21st of 47 higher than 27 of 47 other Lung Non-Small Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lung Non-Small Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06918132, the US trial registry maintained by the National Library of Medicine. NCT06918132 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.