Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery

NCT04991025 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 21-152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.

Conditions

Lung Cancer; Lung Cancer Stage II; Lung Cancer Stage III

Keywords

Untreated Lung Cancer; resectable lung cancer; operable lung cancer; Certolizumab; Memorial Sloan Kettering Cancer Center; 21-152

Outcome Measures

Primary Outcomes (1)

• Participants complete pathologic response (CPR)

  To evaluate the complete pathologic response (CPR) of participants with stage II-III lung cancers who receive treatment with neoadjuvant platinum-based chemotherapy + certolizumab pegol. Major pathologic response (MPR) is defined as 10% or less residual viable tumor after neoadjuvant therapy

  up to 2 years

Study Arms (2)

Participants with resectable stage II-III lung cancers (Adenocarcinoma)

EXPERIMENTAL

This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + nivolumab + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.

Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin; Drug: Certolizumab; Drug: Nivolumab

Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

EXPERIMENTAL

This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + nivolumab + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.

Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin; Drug: Certolizumab; Drug: Nivolumab

Interventions

Cisplatin DRUG

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Pemetrexed DRUG

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Gemcitabine DRUG

Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Carboplatin DRUG

Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Certolizumab DRUG

Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Nivolumab DRUG

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 + nivolumab 360mg intravenously on day 1 of a 21 day cycle Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of 21 day cycle + nivolumab 360mg IV on day 1 of 21 day cycle.

Participants with resectable stage II-III lung cancers (Adenocarcinoma); Participants with resectable stage II-III lung cancers (squamous cell carcinoma)

Eligibility Criteria

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

You may qualify if:

• Untreated stage II-III (AJCC 8th edition) non-small cell lung cancers with operable and resectable disease determined by a thoracic surgeon
• Histologic confirmation of disease at MSKCC
• Age 18 years or older
• Karnofsky Performance Status ≥ 70
• Adequate bone marrow, liver and renal function, as specified below:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9 /L
• Lymphocyte count ≥0.5 x10\^9/L (500/µL)
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100 x 10\^9 /L
• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
• AST and ALT ≤ 2.5 x ULN
• Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
• Serum albumin ≥25 g/L (2.5 g/dL)
• For patients not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

You may not qualify if:

• Presence of an FDA approved targeted therapy for patients with NSCLC harboring a genomic aberration for which an FDA-approved targeted therapy is indicated
• Hypersensitivity to platinum agents
• Prior use of TNF-α inhibitor
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
• Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
• Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
• Topical steroids
• Active or history of autoimmune disease or immune deficiency
• Active or history of autoimmune disease or immune deficiency including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, antiphospholipid antibody syndrome Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis.
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover \< 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Pemetrexed; Gemcitabine; Carboplatin; Certolizumab Pegol; Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Paul Paik, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Paik, MD

CONTACT

646-608-3759; paikp@mskcc.org

Matthew Bott, MD

CONTACT

212-639-5944; bottm@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: October 19, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7)