Nimotuzumab and Nivolumab in Treating Patients With Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02947386|
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : May 26, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02947386
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Grace K. Dy|
|Principal Investigator:||Grace Dy||Roswell Park Cancer Institute|