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Nimotuzumab and Nivolumab in Treating Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02947386
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : October 22, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This phase I/II trial studies the best dose and side effects of nimotuzumab when giving together with nivolumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may block tumor growth in different ways by targeting certain cells.

Condition or disease Intervention/treatment Phase
EGFR Gene Mutation Recurrent Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer Other: Laboratory Biomarker Analysis Biological: Nimotuzumab Biological: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open-Label Study of Nimotuzumab in Combination With Nivolumab in Patients With Advanced Non-small Cell Lung Cancer
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Treatment (nivolumab, nimotuzumab)
Patients receive nivolumab IV over 60 minutes and nimotuzumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Nimotuzumab
Given IV
Other Names:
  • Thera-CIM-hr3
  • TheraCim hR3
  • Theraloc

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Primary Outcome Measures :
  1. DLT as graded by NCI CTCAE version 4.0 (Phase I) [ Time Frame: Up to 28 days ]
    No formal analyses of DLTs are planned. Participants who do not have a DLT and who do not complete a full cycle of treatment will be considered non-evaluable for DLT.

  2. ORR defined as complete response (CR) + partial response (PR) divided by number of patients as assessed by RECIST version 1.1 (Phase II) [ Time Frame: Up to 3 years ]
    Will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. The 95% confidence interval for ORR (CR + PR) will be presented based on the Wilson Score method as irRC response.

Secondary Outcome Measures :
  1. Incidence of adverse events assessed by NCI CTCAE version 4.0 (Phase I and II) [ Time Frame: Up to 30 days after the last dose of study treatment ]
    The frequency of AEs will be tabulated by grade across all dose levels and cycles. All patients who receive any study treatment will be considered evaluable for toxicity.

Other Outcome Measures:
  1. EGFR expression in tumor tissue (Phase I and II) [ Time Frame: Up to 3 years ]
    Examined using Kaplan-Meier plots and log-rank tests or proportional hazards models for time-to-event data, and presentation of frequencies and proportions and exact tests for binary and categorical data.

  2. PD-L1 expression in tumor tissue (Phase I and II) [ Time Frame: Up to 3 years ]
    Examined using Kaplan-Meier plots and log-rank tests or proportional hazards models for time-to-event data, and presentation of frequencies and proportions and exact tests for binary and categorical data.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Patients with pathologically confirmed non-small cell lung cancer
  • Patients must have had progressive NSCLC after first-line platinum-based chemotherapy for advanced disease
  • Have at least 3 months life expectancy
  • Have measurable disease per RECIST 1.1 criteria present
  • Patients with adenocarcinoma known to have anaplastic lymphoma kinase (ALK) rearrangements and/or epidermal growth factor receptor (EGFR) mutations that have had prior EGFR or ALK tyrosine kinase inhibitor therapy and have progressed, will also be eligible, regardless of line of therapy
  • Phase I optional archival tissue/phase II mandatory archival tissue: able to provide enough biopsy tissue samples including primary diagnostic biopsy (archival), re-biopsy tissues (archival from time of disease progression/recurrence following first-line treatment failure) at disease progression to determine PD-L1 and EGFR expression and other biomarkers
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin >= 9 g/dL
  • Serum creatinine =< 1.5 x institution upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 1.5 x ULN or =< 5 x ULN if liver metastases are present
  • Total serum bilirubin =< ULN; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's syndrome
  • Troponin-I, CK-MB +< BNP <200pg/ml
  • LVEF >= LLN
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Active autoimmune disease that has required systemic treatment in past 2 years; use of inhaled corticosteroids is allowed
  • Phase II only: history of other malignancies are allowed as long as the current disease stage that did not require active treatment with concomitant systemic cytotoxic chemotherapy, targeted therapy, investigational or biologic therapy (e.g., anti-CTLA4 or HER2 monoclonal antibodies) within 12 months prior to study registration and, is not likely to require systemic therapy in the next 12 months; hormone-related therapies (e.g., somatostatin analogues, etc.) are allowed on a case-to-case basis upon discussion with principal investigator
  • Active clinically serious infections requiring antibiotics, antiviral or antifungal agents
  • Symptomatic brain metastases; uncontrolled pleural effusion, seroperitoneum, or pericardial effusion
  • Has had any major surgery, chemotherapy, or radiotherapy within the previous 4 weeks; gamma knife radiosurgery for brain metastases within less than 2 weeks
  • Receiving other anti-cancer medical treatment during the study outside of the nimotuzumab or nivolumab
  • Clinically significant interstitial pulmonary disease or known diagnosis of interstitial lung disease (ILD)
  • Has known immunosuppressive disease (e.g. human immunodeficiency virus [HIV], acquired immune deficiency syndrome [AIDS])
  • Patient has known hypersensitivity to the components of the study drugs or their analogs
  • Patient with uncontrolled cardiac disease or cardiac dysfunction, including any of the following:

    • History of uncontrolled angina pectoris that does not respond to medical intervention
    • Symptomatic pericarditis or myocardial infarction within 12 months prior to study entry that did not respond to treatment
    • History of documented congestive heart failure (New York Heart Association functional classification III or IV)
    • Documented cardiomyopathy
    • Uncontrolled hypertension defined by: systolic blood pressure (SBP) >= 160 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02947386

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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724   
Principal Investigator: Grace K. Dy         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Grace Dy Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT02947386    
Other Study ID Numbers: I 281616
NCI-2016-01476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 281616 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action