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Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1

ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

This is a single arm phase II trial enrolling patients with stage II-IIIA non-small cell lung cancer whose disease is deemed amenable for surgical resection and has a PD-L1 level of ≥50%. Patients will receive cemiplimab for 3 cycles followed by surgical resection. The primary endpoint evaluated by the study is the amount of residual tumor in the resected tissue after 3 cycles of cemiplimab. After surgery, all patients will receive additional 10 cycles of cemiplimab and the treating oncologist will decide on the need of administering chemotherapy prior to that.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is willing and able to give informed consent for participation in the trial

Male or Female, aged 18 years or above

ECOG 0-1

Patient diagnosed with early-stage resectable stage II to IIIA squamous or non-squamous, operable treatment naïve NSCLC with PD-L1 TPS ≥50%. Patients who are eligible for standard of care treatment are allowed as well as those who are ineligible for chemo, if they fit the rest of the criteria

Disqualifiers

Patients showing evidence of any distant metastases during screening.

Patients with tumors with known actionable EGFR gene mutations, ALK, RET or ROS1 gene translocations

Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.

Significant renal or hepatic impairment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cemiplimab

    Drug

    Cemiplimab 350 mg IV every 3 weeks for 3 neoadjuvant cycles, followed by surgical resection, then 10 adjuvant cycles of cemiplimab at the same dose and schedule.

  • Adjuvant chemotherapy

    Drug

    Up to 4 cycles of histology-matched platinum-based adjuvant chemotherapy may be administered after surgery, at the treating oncologist's discretion, prior to starting adjuvant cemiplimab.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Perioperative CemiplimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathologic Complete Response Rate

Time frame
At surgical resection visit

Secondary outcomes

1

Event-Free Survival

Time from treatment initiation to first occurrence of disease progression, recurrence, development of unresectable disease, death from any cause, or end of study follow-up.

Time frame
From treatment initiation until event or end of follow-up.
2

Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0

Treatment-related adverse events graded per CTCAE v5.0.

Time frame
From first dose through end of treatment and safety follow-up
3

Correlation of MRD Status With pCR, EFS, and OS

Time frame
Baseline, surgical resection visit, and at 6,9, and 12 months after surgery
4

MRD Status by MRD Assay

Time frame
Baseline, post-resection, and at 6, 9, and 12 months after surgery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: