Active Not RecruitingPhase 1NCT05704634
Official study title

A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.

Study summary

To learn if the combination of sarilumab (also called Kevzara) and cemiplimab can help to control EGFR- or LKB1/STK11-mutant NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCemiplimab and Kevzara (Sarilumab)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 6, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Cemiplimab; Drug: Kevzara (Sarilumab)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Subject must meet all of the following applicable inclusion criteria to participate in this study: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. Histologically or cytologically confirmed non-squamous, non-small cell lung cancer 4. Locally advanced or metastatic disease. 5. Patients must have one of the following: Cohort A:
  • NSCLC which harbours EGFR Exon 19 deletion.
  • NSCLC which harbours EGFR L858R mutation.
  • NSCLC with activating EGFR exon20 insertion or exon 18/21 atypical mutations EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed) The documentation of EGFR mutation status can be obtained any time since the initial diagnosis of non-small cell lung cancer. For cohort A, the patient must have received an EGFR TKI treatment, if approval targeted therapy exists. For patients whose tumor harboring EGFR Exon19 deletion or L858R mutation, prior osimertinib treatment is required, unless contraindicated for medical reasons. Cohort B:
  • NSCLC which harbours LKB1 mutation. LKB1 mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed) The documentation of LKB1 mutation status can be obtained any time since the initial diagnosis of non-small cell lung cancer. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A) 7. At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline at equal or greater than 10mm in the longest dimension by RECIST 1.1. 8. Prior treatment with cytotoxic chemotherapy or immunotherapy is allowed for both cohorts. Up to 3 lines of prior therapy is allowed. 9. Patients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes:
  • ANC \>/= 2,000/mm3 and white blood cells \>/= 3,000/mm3
  • platelet count \>/=150,000/mm3
  • HgB ≥ 8.5 g/dL
  • Creatinine ≤ 30 mL/minute (using Cockroft-Gault formula).
  • Total Serum Bilirubin ≤ ULN (unless with documented Gilbert Syndrome diagnosed by genetic testing)
  • SGOT, SGPT ≤ 1.5 X ULN
  • Cholestrol ≤ 350 mg/dL, 9.1 mmol/L, and triglyceride ≤ 500 mg/dL, 5.6 mmol/. 10. Females of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test within 7 days of starting of treatment. The patient must agree to use adequate contraception for a minimum of two weeks prior to receiving study medication until 3 months after discontinuation of the study medication. Acceptable methods of contraception include total and true sexual abstinence, hormonal contraceptives that are not prone to drug-drug interactions (IUS Levonorgestrel Intra Uterine System (Mirena), Medroxyprogesterone injections (Depo-Provera)), copper-banded intra-uterine devices, and vasectomized partner. All hormonal methods of contraception should be used in combination with the use of a condom by their sexual male partner. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following age-specific requirements must also apply: Women \< 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) must also be in the post-menopausal range (as per the institution). Women ≥ 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses \> 1 year ago, or have had chemotherapy-induced menopause with \>1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy. 11. Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 3 months after the last dose of study medication. Adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Patients should not father a child for 6 months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication. 12. Patients who meet eligibility criteria to either Cohort A or B will be allowed to enroll to the run-in cohort.
Reasons someone may not be able to joinExclusion criteria

Subjects should not enter the study if any of the following

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • M D Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 6, 2026. Always confirm current availability with the study team.

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