Small Cell Lung CarcinomaPhase 2NCT03662074
Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer
A Phase 2 study testing Gemcitabine and Nivolumab in people with Small Cell Lung Carcinoma and Stage IV Lung Cancer AJCC v8, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8
- What is being tested?
- Gemcitabine and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 3 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone.
SECONDARY OBJECTIVES:
- 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.
EXPLORATORY OBJECTIVES:
- 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).
OUTLINE:
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.
- Conditions
- Small Cell Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Being tested
- Gemcitabine, Nivolumab
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Gemcitabine; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (5)
Overall Survival (OS) - Number of Participants
OS will be estimated using standard Kaplan Meier survival analysis methods.
Measured: Duration of time from the start of treatment to date of death, assessed up to 2 years
Overall Survival (OS) - Months
A median value (months) of overall survival will be estimated using standard Kaplan Meier survival analysis methods.
Measured: Duration of time from the start of treatment to date of death, assessed up to 2 years
Progression-free Survival (PFS) - Number of Participants
Progression-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progression-Free Survival (PFS) is defined as the duration of time from the start of treatment to the time of investigator assessed progression or death. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions
Measured: 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
A median value (months) of progressive-free survival will be estimated using standard Kaplan Meier survival analysis methods. Progressive Disease (PD): Increase by ≥ 20% in sum of longest diameter of target lesions or the appearance of one or more new lesions
Measured: 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
Toxicity rates will be estimated by responder status and presented overall and by body site per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start7 Nov 2018
- Primary completion7 Oct 2020
- Study completion3 Feb 2022
Why it stopped: After interim analysis decided not to move forward with continuing the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas W. Lycan, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662074
- Sponsor's protocol ID
- IRB00051024
- Other IDs
- NCI-2018-01803, CCCWFU 62418, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2018
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Subsequent Line Gemcitabine and Nivolumab for Advanced SCLC
- ClinicalTrials.gov ID
- NCT03662074
- Acronym / sponsor ID
- IRB00051024
- Conditions
- Small Cell Lung Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After interim analysis decided not to move forward with continuing the trial.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 12 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To compare response rate (RR) of gemcitabine and nivolumab (G+N) after 4 cycles (8 weeks) to historical controls treated with nivolumab alone.
SECONDARY OBJECTIVES:
- 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.
EXPLORATORY OBJECTIVES:
- 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).
OUTLINE:
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (gemcitabine, nivolumab) | Experimental | Drug: Gemcitabine, Biological: NivolumabParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: dFdC, dFdCyd, DifluorodeoxycytidineGiven IV | Drug | Treatment (gemcitabine, nivolumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Treatment (gemcitabine, nivolumab) |
Primary outcome
Number of Participants With Positive Responses to Therapy 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. * 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.
5 secondary outcomes
Overall Survival (OS) - Number of Participants
Time frame: Duration of time from the start of treatment to date of death, assessed up to 2 years
Overall Survival (OS) - Months
Time frame: Duration of time from the start of treatment to date of death, assessed up to 2 years
Progression-free Survival (PFS) - Number of Participants
Time frame: 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
Time frame: 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
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W. Lycan principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Nivolumab in people with Small Cell Lung Carcinoma and Stage IV Lung Cancer AJCC v8, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Positive Responses to Therapy Per Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.