Experimental combo targets Hard-to-Treat lung cancer

NCT ID NCT02812667

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

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