A Study of Chemotherapy and Certolizumab in People Who Have Lung Cancer That Can Be Treated With Surgery

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Carboplatin; Certolizumab Pegol; Gemcitabine; Pemetrexed

Criteria

Inclusion Criteria:

• Untreated stage II-III 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

• Hemoglobin ≥ 8 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.

• Negative PPD test

• For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment

• Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter

• Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors 1.1

• Ability to provide written, informed consent. Legally Authorized Representatives are permitted.

Exclusion Criteria:

• 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

• Ongoing use of investigational agents or use of investigational agents within the last four weeks

• Prior use of TNF-α inhibitor

• History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis

• Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)

• Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush

• Active tuberculosis or untreated, latent tuberculosis

• If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.

• Acute or chronic Hepatitis B or C infection

• Known HIV infection requiring antiretroviral medications and those with AIDS

• Active herpes zoster infection

• Non-healed infected skin ulcers

• History of myocardial infarction or unstable angina within the past 12 months

• Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids

• Women who are breastfeeding

• Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast