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.

NCT05704634 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-1194NCI-2023-00573
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 2 years

Study Arms (2)

Cohort A : EGFR-mutant cohort

EXPERIMENTAL

Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.

Drug: Cemiplimab; Drug: Kevzara (Sarilumab)

Cohort B: LKB1-mutant cohort

EXPERIMENTAL

Each cohort is planned for 30 Participants with a total of 60 Participants. Participants who are treated in Run-In safety cohort can also be evaluated for efficacy in the molecularly define cohort A or B.

Drug: Cemiplimab; Drug: Kevzara (Sarilumab)

Interventions

Cemiplimab DRUG

Given by Injection under the skin every 2 weeks

Cohort A : EGFR-mutant cohort; Cohort B: LKB1-mutant cohort

Kevzara (Sarilumab) DRUG

Given by IV (vein) over about 30 minutes every 3 weeks.

Cohort A : EGFR-mutant cohort; Cohort B: LKB1-mutant cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years at the time of consent.
• Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
• Locally advanced or metastatic disease.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A)

You may not qualify if:

• Spinal cord compression or brain metastases unless asymptomatic or stable for at least 2 weeks prior to start of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment.
• Any evidence of severe or uncontrolled systemic diseases. Screening for chronic conditions is not required.
• Woman of childbearing potential (WOCBP) not protected by highly-effective contraceptive method(s) of birth control, and/or who are unwilling or unable to be tested for pregnancy.
• Pregnant or breastfeeding woman
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement.
• Active or severe autoimmune disorders, including rheumatoid arthritis
• Active TB or a history of incompletely treated TB regardless of screening Quantiferon result
• Quantiferon positive patients (no active disease) are excluded from the study unless the following conditions are met:
• Patients with a history of prior documented completed chemoprophylaxis for latent tuberculosis infection (eg, acceptable treatments include 9 months of isoniazid 300 mg oral daily or equivalent proven regimen per local guidelines) or treatment of active tuberculosis infection (TBI) who has obtained consultation with a specialist to rule out active TBI or the need to receive further treatment.
• Patients with no prior history of chemoprophylaxis for latent TBI or treatment for active TBI but have obtained consultation with a specialist to initiate an appropriate regimen of chemoprophylaxis, based on local epidemiology and applicable guidelines and have demonstrated compliance and tolerated treatment for 1 month.
• Consultations with and prior approval from IND sponsor are required in either of the aforementioned scenarios.
• Clinically significant abnormality consistent with prior/active TB infection based upon chest radiograph with at least posterior-anterior view (See Section 10.8.1). Additional lateral view is recommended but not required.
• Suspected extra-pulmonary TB infection regardless of screening Quantiferon result.
• Patients at high risk of contracting TB, such as close contact with individuals with active or latent TB.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

cemiplimab; sarilumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiuning Le, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)