A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:September 4, 2015
End Date:June 20, 2019

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An Open-Label, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab With Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer

The main purpose of this study is to evaluate the safety and efficacy of the combination of
necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer
(NSCLC).


Inclusion Criteria:

- The participant has Stage IV NSCLC.

- Part A: NSCLC Stage IV (any type)

- Part B: NSCLC Stage IV (squamous and nonsquamous)

- Part C: NSCLC Stage IV in Japanese participants (squamous and nonsquamous)

- The participant must have progressed after 1 platinum-based chemotherapy regimen for
Stage IV NSCLC. Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior
neoadjuvant/adjuvant therapy is permitted. Prior treatment with EGFR-TKI and ALK
inhibitors is mandatory in participants with NSCLC whose tumor has EGFR-activating
mutations or ALK translocations, respectively.

- Measurable disease at the time of study entry as defined by Response Evaluation
Criteria In Solid Tumors Version 1.1 (RECIST 1.1).

- The participant has evaluable tumor tissue available for biomarker analyses.

- The participant has adequate organ function.

- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.

Exclusion Criteria:

- The participant is currently enrolled in a clinical trial involving an investigational
product or non-approved use of a drug or device.

- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibody.

- Have a serious concomitant systemic disorder or significant cardiac disease.

- The participant has undergone major surgery or received anti-cancer monoclonal
antibody therapy in the 30-days prior to study enrollment.

- The participant has undergone chest irradiation within 2 weeks prior to receiving
study treatment.

- The participant has brain metastases that are symptomatic.

- The participant has a history of arterial thromboembolism event (ATE) or venous
thromboembolism event (VTE) within 3 months prior to study enrollment. Participants
with history of VTE beyond 3 months prior to study enrollment can be enrolled if they
are appropriately treated with low molecular weight heparin.

- The participant has a known allergy / history of hypersensitivity reaction to any of
the treatment components, including any ingredient used in the formulation of
necitumumab or pembrolizumab, or any other contraindication to one of the administered
treatments.

- The participant has a concurrent active malignancy. Previous history of malignancy is
permitted, provided that the participant has been free of disease for ≥3 years, with
the exception of adequately treated basal or squamous cell carcinoma of the skin,
preinvasive carcinoma of the cervix, or any cancers that in the judgment of the
investigator and sponsor may not affect the interpretation of results (for example,
prostate, bladder).

- History of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that
requires steroids or immunosuppressive agents.

- The participant has active infection requiring systemic therapy, including active
tuberculosis or known history of infection with the human immunodeficiency virus (HIV
1/2 antibodies), or hepatitis B (e.g., HBsAg reactive) and/or C virus (e.g., HCV RNA
[qualitative] is detected).

- The participant has an active autoimmune disease or a documented history of autoimmune
disease, or a syndrome that requires systemic steroids or immunosuppressive agents.

- The participant has received a live vaccine within 30 days prior to the first dose of
trial treatment.
We found this trial at
4
sites
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Phone: 239-274-9930
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Melissa Johnson
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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