Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas

NCT02120807 | Completed Phase 1

• 1 other identifier: 13-063
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to test the safety of certolizumab when it is given with the chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy drugs used in the treatment of lung cancer. The investigators want to find out what effects, good and/or bad, certolizumab has on the patient and lung cancer.

Conditions

Stage IV Lung Adenocarcinoma

Keywords

Certolizumab; Cisplatin; Pemetrexed; thoracic; 13-063

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated does (MTD)

  A standard 3+3 dose-escalation scheme will be used to test two doses of certolizumab: dose level A (200mg) and dose level B (400mg), in combination with the standard dose of chemotherapy. In addition, two de-escalation doses are planned, if dose level A proves too toxic: dose level C (chemotherapy at 75% of the standard dose + certolizumab 200mg) and dose level D (chemotherapy at 75% of the standard dose + certolizumab 400mg)..The MTD is the highest dose at which ≤ 1/6 patients experiences a DLT. Please see the dose escalation schema for exact dose level details.

  2 years

Secondary Outcomes (2)

• Progression-free survival (PFS)

  2 years

• Immunohistochemical staining

  2 years

Study Arms (1)

certolizumab, cisplatin and pemetrexed

EXPERIMENTAL

Patients will receive certolizumab with 6 cycles of cisplatin \& pemetrexed. Cycle of chemo will be 3 weeks. Certolizumab will be adm in the following fashion: first dose administered at the time of treatment initiation, second dose will be given after 2 weeks of treatment, third dose after four weeks of treatment, \& subsequent doses given every 4 weeks thereafter. Patients will be monitored for progression of disease using RECIST 1.1 with scans to be performed every 6 weeks. Posttreatment biopsies will be performed at the time of treatment discontinuation. Two dose levels of certolizumab will be tested, 200mg \& 400mg. A non-therapeutic cohort of 10 patients with adenocarcinomas who will be undergoing standard of care treatment with platinum based chemotherapy + pemetrexed +/- bevacizumab will be consented for blood draws before each cycle of treatment. This blood will be analyzed for cytokines and will serve as a reference for the experimental arm.

Drug: Certolizumab; Drug: cisplatin; Drug: pemetrexed

Interventions

Certolizumab DRUG

certolizumab, cisplatin and pemetrexed

cisplatin DRUG

certolizumab, cisplatin and pemetrexed

pemetrexed DRUG

certolizumab, cisplatin and pemetrexed

Eligibility Criteria

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

You may qualify if:

• Previously untreated stage IV lung adenocarcinoma confirmed at MSKCC
• Age 18 years or older
• Karnofsky Performance Status ≥ 70
• Patients with locally treated, stable, and/or asymptomatic brain metastases are eligible.
• Adequate bone marrow, liver and renal function, as specified below:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• Hemoglobin ≥ 8 g/dL
• Platelets ≥ 100 x 109/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 or ≤ 5 x ULN if liver metastases are present
• 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

You may not qualify if:

• Hypersensitivity to platinum agents
• Ongoing use of investigational agents or use of investigational agents within the last four weeks
• Prior use of agents for TNF-alpha blockade
• 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
• o 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Certolizumab Pegol; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; 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, Dicarboxylic

Study Officials

• Paul Paik

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: April 15, 2014
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (6)