Experimental combo targets Hard-to-Treat lung cancer
NCT ID NCT02812667
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a combination of two drugs—nivolumab, a standard immunotherapy, and plinabulin, an experimental drug that attacks tumor blood vessels—in 18 people with advanced non-small cell lung cancer that had worsened after chemotherapy. The main goals were to find a safe dose and check for side effects. Researchers also tracked whether tumors shrank or stopped growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and plinabulin
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced lung cancer patients who have run out of standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and dosing, not effectiveness. The drug combination may cause side effects or fail to shrink tumors.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Aug 2016
- Finished
-
Oct 2025
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Subjects with histologically or cytologically-confirmed metastatic NSCLC whose disease progressed during/after treatment with at least one platinum-containing chemotherapy regimen. * At least 1 prior systemic therapy for metastatic disease. Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless patients progressed within 6 months of completion of chemotherapy * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 * Life expectancy ≥ 12 weeks * Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST). * Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings. * Prior chemotherapy must have been completed at least 4 weeks or at least 5 half-lives (whichever is longer) before study drug administration, and all adverse events have either returned to baseline or stabilized * Prior treated brain metastases are allowed. However, prior treated brain metastases must be without MRI evidence of progression for at least 4 weeks and off systemic steroids for at least 2 weeks before study drug administration * Prior definitive radiation therapy must have been completed at least 4 weeks before study drug administration. Prior palliative radiotherapy should be completed at least 2 weeks before study drug administration. Whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS) and focal radiation to the sites of pain or bronchial obstruction will be considered palliative. No radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration * Prior major surgery must be completed at least 4 weeks before study drug administration. Prior minor surgery must be completed at least 1 week before study drug administration and subjects should be recovered. Percutaneous biopsies should be completed at least 10 days prior to study drug administration; * A negative serum pregnancy test at screening for women of childbearing potential. Exclusion Criteria: * History of grade 3 or above hypersensitivity reactions to other monoclonal antibodies * Subjects with a history of a cardiovascular illness. * Uncontrolled hypertension, SBP\> 160 or DBP\>100 * Symptomatic or untreated brain metastases * Presence of leptomeningeal disease * Pulmonary conditions, which in the PI's opinion would increase the risk of immunotherapy-related pulmonary toxicity. * Has active, non-infectious pneumonitis * Presence of a second malignancy, excluding non-melanomatous skin cancer unless in remission for 3 years * Subjects with any active, known, or suspected autoimmune disease. * History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility. * Prior therapy with microtubule destabilizing agents for NSCLC (ie. Vinorelbine) * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways); * Known history of Human Immunodeficiency Virus; * Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) * Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events * Concurrent medical condition requiring the use of immunosuppressive medications, or systemic steroids. * Use of other investigational drugs within 28 days or at least 5 half-lives before study drug administration * Pregnant or nursing
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non small cell lung cancer metastatic are added.
By submitting, you agree to our Terms of use
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
-
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a triple-drug cocktail re-sensitize lung cancer to treatment?
- Could a lung cancer drug designed for one mutation work for another?
- Could chemo plus immunotherapy double the punch against tough lung cancers?
- Should all advanced lung cancer patients get a brain scan? new trial aims to find out
- New hope for tough lung cancer? trial tests targeted drug against chemo
- New combo therapy for lung cancer under Real-World watch