Lung Cancer, Lung Cancer Stage II, Lung Cancer Stage III
Conditions
Keywords
Untreated Lung Cancer, resectable lung cancer, operable lung cancer, Certolizumab, Memorial Sloan Kettering Cancer Center, 21-152
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.
Interventions
DRUGCisplatin
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.
DRUGPemetrexed
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
DRUGGemcitabine
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.
DRUGCarboplatin
Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.
DRUGCertolizumab
Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.
DRUGNivolumab
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Negative PPD test or interferon-gamma release assay (including but not limited to QuantiFERON-TB Gold) * 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 5 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. * Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ³ 200/µL, and have an undetectable viral load * Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. Note: The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test. * Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
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 * 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 Note: this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants complete pathologic response (CPR) | up to 2 years | 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 |
Countries
United States
Contacts
Primary ContactPaul Paik, MD
Backup ContactMatthew Bott, MD
Outcome results
None listed