Can a Chemo-Immunotherapy duo outsmart tough lung cancer?
NCT ID NCT03662074
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This phase II pilot trial is asking whether combining the chemotherapy drug gemcitabine with the immunotherapy drug nivolumab can shrink tumors in people with advanced small cell lung cancer that has spread and no longer responds to initial treatment. The study enrolls about 14 adults who have already had platinum-based chemotherapy. Researchers will measure how many participants see their tumors shrink and how long they live, comparing the results to a historical benchmark to see if the combo is worth pursuing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine and nivolumab
- What this could lead to
- If this combination works, it could offer a new treatment option for people with advanced small cell lung cancer who have run out of standard therapies.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The combination may not shrink tumors enough to be better than existing options, and both drugs can cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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14 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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Feb 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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