Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic 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.|
|ClinicalTrials.gov Identifier: NCT03662074|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8||Drug: Gemcitabine Biological: Nivolumab||Phase 2|
I. To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone.
I. To compare median overall survival (OS) of G+N to historical controls treated with nivolumab alone.
II. To compare median progression-free survival (PFS) of G+N to historical controls treated with nivolumab alone.
III. To evaluate for tolerability of G+N at each treatment cycle and then every 8 weeks after treatment is completed.
I. To correlate immunophenotypic changes among lymphocytes (quantitative measurements of CD4 and CD8 T-cells) with radiographic response and overall survival before treatment, after treatment and between 8-12 weeks after treatment.
II. Among those patients with tumor mutation burden (TMB) status available, to describe the association between TMB (low, medium, or high) and RR, OS, and PFS.
III. Assess the patient perspective of symptomatic adverse events using self-reported items from the National Cancer Institute (NCI) Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Participants receive gemcitabine intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days, 6-10 weeks, and every 8 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC|
|Actual Study Start Date :||November 7, 2018|
|Estimated Primary Completion Date :||September 10, 2020|
|Estimated Study Completion Date :||September 10, 2021|
Experimental: Treatment (gemcitabine, nivolumab)
Participants receive gemcitabine IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
- Radiographic response rate (RR) per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 8 weeks ]Objective RR (complete response [CR] + partial response [PR]) will be compared between this study sample and a historical benchmark value of 10%. For this comparison we will use a one-sample test of proportion.
- Overall survival (OS) [ Time Frame: Duration of time from the start of treatment to date of death, assessed up to 2 years ]OS will be estimated using standard Kaplan Meier survival analysis methods.
- Progression-free survival (PFS) [ Time Frame: Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years ]PFS will be estimated using standard Kaplan Meier survival analysis methods.
- Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: Up to 2 years ]Toxicity rates will be estimated by responder status and presented overall and by body site.
- Immunophenotypic changes among lymphocytes (CD4 versus CD8) [ Time Frame: Baseline, post-treatment, and at 6-10 weeks ]Will assess association between clinical outcomes (RR, OS, PFS) with immunophenotypic changes among lymphocytes. Changes in T regulatory cell concentrations will be assessed in each arm. These measures will be compared longitudinally to examine whether changes in certain biomarkers are associated with participants who experience an objective response. Peripheral blood samples at 3 time points (baseline before study treatment, post-treatment, and at follow-up [between 6 and 10 weeks post-treatment]) will be analyzed by flow cytometry.
- Tumor mutation burden (TMB) [ Time Frame: Up to 2 years ]Will assess clinical outcomes (RR, OS, PFS) and association with TMB. Assessed as (low, 0 to < 143; medium, 143 to 247; or high, > 248). TMB status (low, medium, or high) will be assessed as to how they relate to RR, OS, and PFS. This subgroup analysis will be in a descriptive manner only due to the small size of the study.
- Participant responses to (Patient Reported Outcomes) PRO-CTCAE items [ Time Frame: Baseline up to 2 years ]Participants self-reported symptoms will be assessed with PRO-CTCAE at patient preference; these scores will be analyzed in a descriptive manner only due to the small size of the study.
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): NCT03662074
|Contact: Study Nursefirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: William J. Petty 336-716-3313 email@example.com|
|Principal Investigator: Thomas W. Lycan|
|Principal Investigator:||Thomas W. Lycan||Wake Forest University Health Sciences|