Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer

NCT03662074 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: IRB00051024NCI-2018-01803CCCWFU 62418P30CA012197
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II pilot trial studies how well gemcitabine and nivolumab work in treating participants with small cell lung cancer that has spread to other parts of the body after other treatments have failed. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving second-line gemcitabine and nivolumab may work better in treating participants with small cell lung cancer.

Conditions

Small Cell Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST)

  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. * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions. The response in non-target lesions is defined as follows: * Complete Response (CR): Complete disappearance of all non-target lesions. * Stable Disease (SD): Persistence of one or more non-target lesion(s). * Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  Up to 8 weeks

Secondary Outcomes (5)

• Overall Survival (OS) - Number of Participants

  Duration of time from the start of treatment to date of death, assessed up to 2 years

• Overall Survival (OS) - Months

  Duration of time from the start of treatment to date of death, assessed up to 2 years

• Progression-free Survival (PFS) - Number of Participants

  Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

• Progression-free Survival (PFS) - Months

  Duration of time from the start of treatment to the time of investigator assessed progression or death, assessed up to 2 years

• Number of Adverse Events

  Up to 2 years

Study Arms (1)

Treatment (gemcitabine, nivolumab)

EXPERIMENTAL

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

Drug: Gemcitabine; Biological: Nivolumab

Interventions

Gemcitabine DRUG

Given IV

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

Treatment (gemcitabine, nivolumab)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

Treatment (gemcitabine, nivolumab)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed incurable SCLC and have had prior treatment with platinum-based chemotherapy. High-grade neuroendocrine tumors that are suspected to be of bronchopulmonary origin can be enrolled if they have had prior treatment with a SCLC chemotherapy regimen (e.g. platinum plus etoposide).
• Patients should not be demonstrating end-organ damage due to rapid progression of disease based on the most recent assessment of the treating physician.
• Patients must have radiographically measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Absolute neutrophil count \>= 1,500/mcL.
• Platelets \>= 100,000/mcL.
• Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.

You may not qualify if:

• Patients who have previously received either gemcitabine or an immune checkpoint inhibitor can be enrolled.
• Emergent need for palliative radiation.
• Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
• History of allergic reaction to gemcitabine.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Gemcitabine; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Nurse
• Organization: Wake Forest Baptist Comprehensive Cancer Center

saverill@wakehealth.edu

336-716-0230

Study Officials

• Thomas W. Lycan

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: November 7, 2018
• Primary Completion: October 7, 2020
• Study Completion: February 3, 2022
• Last Updated: August 2, 2023
• Results First Posted: November 12, 2021

Record last verified: 2023-07

Locations

US (1)