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Could a common antidepressant supercharge lung cancer treatment?

NCT ID NCT06554613

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This phase 2 trial is testing whether adding the antidepressant olanzapine to standard immunotherapy (nivolumab) helps people with advanced EGFR-negative non-small cell lung cancer live longer. About 156 participants will receive either the combination or immunotherapy alone for 6-8 weeks. Researchers will track overall survival and side effects to see if the combination is more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olanzapine (an antidepressant) combined with nivolumab (an immunotherapy drug)
What this could lead to
If it works, this could point toward a more effective first-line treatment for advanced lung cancer by boosting the immune system's response.
What could go wrong
This is a small, early-phase trial, so results may not be conclusive. Olanzapine can cause side effects like drowsiness and weight gain, and the combination may not improve outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2027

An estimate. End dates often move.

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 to 75 years

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: 1. Participants voluntarily enroll in this study and sign an informed consent form, with good compliance and cooperation with follow-up. 2. Age is over 18 years old (including 18 years old) and under 75 years old (including 75 years old). 3. ECOG score: 0-2 points. 4. Expected survival is no less than 3 months. 5. Staged as Stage IV according to the TNM system. 6. Histologically or cytologically confirmed EGFR mutation-negative non-small cell lung cancer. 7. Has not received systemic antitumor treatment, and is intended to receive monotherapy or combined chemotherapy with a PD-1/PD-L1 inhibitor as first-line treatment. 8. Normal major organ function, that is, meeting the following criteria: (1) Hematological examination criteria must be met: Hb≥90 g/L; ANC≥1.5×10\^9/L; PLT≥80×10\^9/L. (2) Biochemical examination must meet the following criteria: TBIL\<1.5×ULN; ALT and AST\<2.5×ULN; serum Cr≤1.25×ULN or endogenous creatinine clearance \> 45 ml/min (Cockcroft-Gault formula). 9. Women of childbearing age must have taken reliable contraceptive measures and have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization. Exclusion Criteria: 1. Have received any of the following treatments: 1. Previously used any EGFR tyrosine kinase inhibitors; 2. Previously received any chemotherapy for lung cancer; 3. Previously received any radiotherapy for lung cancer (except palliative radiotherapy for bone metastases); 4. Within 4 weeks prior to the first administration of the study drug, the subject had undergone major surgery; 5. Within 7 days prior to the first administration of the study drug, used strong inhibitors or inducers of CYP3A4. 2. Subjects with concurrent other malignant tumors, except for basal cell carcinoma of the skin and in situ cancer. 3. Subjects with uncontrollable malignant pleural effusion and pericardial effusion. 4. Subjects allergic to contrast agents for CT and MRI or any subjects who cannot tolerate MRI examination. 5. As judged by the investigator, any serious or poorly controlled systemic diseases, such as uncontrolled hypertension, active bleeding diathesis, or active infection. 6. Clinically severe gastrointestinal functional abnormalities that may affect the intake, transport, or absorption of the drug, such as the inability to take oral medication, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, atrophic gastritis, gastric diseases requiring long-term use of proton pump inhibitors, Crohn's disease, ulcerative colitis, etc. 7. Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis. 8. Meet any of the following cardiac examination results: 1. The average of the corrected QT interval (QTcF) obtained from three ECG examinations at rest is \> 470 msec; 2. Resting ECG suggests conduction or ECG morphological abnormalities (such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval \> 250 msec, etc.); 3. There are any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concurrent medication of unexplained sudden death in direct relatives under the age of 40 or prolonged QT interval; 4. Left ventricular ejection fraction (LVEF) \< 50%. 9. Insufficient bone marrow reserve or organ function, reaching any of the following laboratory limits: 1. Absolute neutrophil count \<1.5×10\^9/L; 2. Platelet count \<100×10\^9/L; 3. Hemoglobin \<90 g/L (\<9 g/dL); 4. If there is no definite liver metastasis, alanine aminotransferase \> 3 times the upper limit of normal (ULN); if there is liver metastasis, alanine aminotransferase \> 5×ULN; 5. If there is no definite liver metastasis, aspartate aminotransferase \>3×ULN; if there is liver metastasis, aspartate aminotransferase \> 5×ULN; 6. If there is no definite liver metastasis, total bilirubin \> 1.5×ULN; or with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastasis, total bilirubin \> 3×ULN; 7. Creatinine \> 1.5×ULN and creatinine clearance \<50 mL/min (calculated by the Cockcroft-Gault formula); creatinine clearance is only required if creatinine \> 1.5×ULN; 8. Serum albumin (ALB) \<28 g/L. 10. Active fungal, bacterial, and/or viral infections requiring systemic treatment. 11. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period. 12. History of interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease. 13. Subjects who, in the judgment of the investigator, may have poor compliance with the procedures and requirements of the study, such as subjects with a clear history of neurological or mental disorders, currently suffering from mental disorders, etc. 14. Subjects whom the investigator judges to have any condition that endangers the safety of the subject or interferes with the evaluation of the study.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.