Non-Small Cell Lung CancerPhase 2NCT06554613
Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
A Phase 2 study testing Olanzapine and Nivolumab in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Clinical Trial The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Olanzapine and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily enroll in this study and sign an informed consent form, with good compliance and cooperation with follow-up.
- Age is over 18 years old (including 18 years old) and under 75 years old (including 75 years old).
- ECOG score: 0-2 points.
- Expected survival is no less than 3 months.
- Staged as Stage IV according to the TNM system.
- Histologically or cytologically confirmed EGFR mutation-negative non-small cell lung cancer.
Show all 9Show fewer
- 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.
- 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).
- 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.
Who cannot join
- Have received any of the following treatments:
- Previously used any EGFR tyrosine kinase inhibitors;
- Previously received any chemotherapy for lung cancer;
- Previously received any radiotherapy for lung cancer (except palliative radiotherapy for bone metastases);
- Within 4 weeks prior to the first administration of the study drug, the subject had undergone major surgery;
- Within 7 days prior to the first administration of the study drug, used strong inhibitors or inducers of CYP3A4.
Show all 31Show fewer
- Subjects with concurrent other malignant tumors, except for basal cell carcinoma of the skin and in situ cancer.
- Subjects with uncontrollable malignant pleural effusion and pericardial effusion.
- Subjects allergic to contrast agents for CT and MRI or any subjects who cannot tolerate MRI examination.
- As judged by the investigator, any serious or poorly controlled systemic diseases, such as uncontrolled hypertension, active bleeding diathesis, or active infection.
- 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.
- Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis.
- Meet any of the following cardiac examination results:
- The average of the corrected QT interval (QTcF) obtained from three ECG examinations at rest is > 470 msec;
- 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.);
- 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;
- Left ventricular ejection fraction (LVEF) < 50%.
- Insufficient bone marrow reserve or organ function, reaching any of the following laboratory limits:
- Absolute neutrophil count <1.5×10^9/L;
- Platelet count <100×10^9/L;
- Hemoglobin <90 g/L (<9 g/dL);
- 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;
- If there is no definite liver metastasis, aspartate aminotransferase >3×ULN; if there is liver metastasis, aspartate aminotransferase > 5×ULN;
- 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;
- 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;
- Serum albumin (ALB) <28 g/L.
- Active fungal, bacterial, and/or viral infections requiring systemic treatment.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- 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.
- 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.
- Subjects whom the investigator judges to have any condition that endangers the safety of the subject or interferes with the evaluation of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Chuyang Lin, Director, 079186300985
About this study
Official title: An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Trial Assessing the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients With Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).
Clinical Trial
The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are:
Read more
Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors?
Participants will:
Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months.
Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.
Keep a record of their symptoms and disease progression.
Read the detailed description
An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Study on the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients with Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).
Primary Research Objective:
To evaluate the objective response rate (ORR) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
Secondary Research Objectives:
To evaluate the interval of progression-free survival (iPFS) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
To evaluate other antitumor efficacy indicators in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine: progression-free survival (PFS), duration of response (DoR), and disease control rate (DCR).
To assess the safety (Safety) and the improvement of quality of life (QoL) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
To explore the impact of antipsychotic medication on the immune response to first-line immunotherapy in advanced NSCLC.
Study Design:
This study is an open-label, two-arm, multicenter, phase II randomized controlled study designed to evaluate and observe the impact of olanzapine on the efficacy of first-line immunotherapy in patients with advanced EGFR mutation-negative NSCLC. Eligible participants who meet all inclusion criteria and do not meet any exclusion criteria will receive first-line treatment with PD-1/PD-L1 monoclonal antibodies alone or in combination with chemotherapy (according to the instructions for use).
Study Subjects:
Ages 18 years and above (including 18) and up to 75 years (including 75); histologically or cytologically confirmed EGFR mutation-negative NSCLC; intended to receive first-line treatment with PD-1/PD-L1 inhibitors alone or in combination with chemotherapy.
Inclusion Criteria:
Participants voluntarily join this study and sign an informed consent form, with good compliance and cooperation with follow-up.
Age is 18 years and above (including 18) and up to 75 years (including 75). ECOG score: 0-2 points. Expected survival is no less than 3 months. Staged as Stage IV according to the TNM system. Confirmed to have NSCLC with EGFR mutation-negative by histology or cytology. Has not received systemic antitumor treatment, and is intended to receive first-line treatment with PD-1/PD-L1 inhibitors alone or in combination with chemotherapy.
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<1.5ULN; ALT and AST<2.5ULN; serum Cr≤1.25ULN or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula).
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.
Data Analysis/Statistical Methods:
Common Analysis This study will summarize the data using corresponding descriptive statistics according to the type of data, that is, for quantitative data, mean (Mean), standard deviation (SD), median (Median), minimum value (Minimum), and maximum value (Maximum) will be used, and for count data and grade data, frequency and percentage will be used, and time-event data will be estimated by the Kaplan-Meier method for the median time and the overall 95% confidence interval.
Efficacy Analysis The primary efficacy endpoint, the objective response rate (ORR) based on the investigator's assessment, will be compared between groups using the Fisher's exact probability test and the two-sided 95% confidence interval will be listed.
The secondary efficacy indicators, including the interval of progression-free survival (iPFS), progression-free survival (PFS), duration of response (DoR), and disease control rate (DCR), will be estimated using the Kaplan-Meier method for the median time and the median event and the two-sided 95% confidence interval will be listed, and the hazard ratio and its 95% confidence interval will be estimated. The disease control rate (DCR = CR + PR + SD) will be compared between groups using Fisher's exact probability test and the two-sided 95% confidence interval will be listed. Quality of life score statistical tests will use ANOVA or two-sided t-tests, and a P-value less than or equal to 0.05 will be considered statistically significant. Comparisons of changes before and after within groups will be made using paired t-tests.
Safety Analysis Safety analysis will mainly summarize descriptive statistics. Statistics will be summarized for adverse events (AEs) and treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory data, vital signs, etc. At the same time, statistical summaries will be made for the exposure to the study drug (including treatment cycles, total dose received, and dose intensity). The above data will be analyzed and summarized according to the current clinical trial reporting standards. Including: summary of adverse events (all causes and related to treatment); incidence and severity of adverse events (all causes and related to treatment); analysis of adverse events related to the drug; analysis of the outcome of adverse events; analysis of serious adverse events.
Sample Size Estimation:
This study is an open-label, two-arm, multicenter, phase II randomized controlled study. The primary research objective is to evaluate the objective response rate (ORR) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine. The study endpoint is the objective response rate (ORR) of the patients. Referring to historical literature, the ORR of first-line chemotherapy combined with immunotherapy in advanced NSCLC patients is about 50%, and it is expected that the combination with olanzapine can increase the ORR by 15%. After the first subject is enrolled, the longest observation period is 24 months, with α being two-sided 0.05, and the power being 90%, the study plans to enroll 156 subjects, with 78 in the experimental group and 78 in the control group, calculated with a 10% loss to follow-up rate.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Olanzapine, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Olanzapine 5mg qd (once daily), q3w(every 3 weeks), oral therapy，Administered continuously for 6-8 weeks.
NivolumabDrug
Also called Opdivo
Nivolumab，Infused intravenously once every 3 weeks at a dose of 2mg/kg, with a continuous 21-day treatment period constituting one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment Group | Experimental | Receiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle.Then receive olanzapine orally at a dose of 5mg once daily (qd), with continuous administration for 6-8 weeks. Receives: Drug: Olanzapine; Drug: Nivolumab |
| Group Without Olanzapine | Active comparator | Receiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle.. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Survival（OS）
The Overall Survival（OS），From the time of a patient's diagnosis or the commencement of treatment, to the time of the patient's death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Chuyang, Director, Study director, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554613
- Sponsor's protocol ID
- IIT-2024-6804
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang M, Herbst RS, Boshoff C. Toward personalized treatment approaches for non-small-cell lung cancer. Nat Med. 2021 Aug;27(8):1345-1356. doi: 10.1038/s41591-021-01450-2. Epub 2021 Aug 12.
PubMed 34385702Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Trial Assessing the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients With Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT06554613
- Acronym / sponsor ID
- IIT-2024-6804
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial
The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are:
Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors?
Participants will:
Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months.
Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.
Keep a record of their symptoms and disease progression.
Detailed description
An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Study on the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients with Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).
Primary Research Objective:
To evaluate the objective response rate (ORR) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
Secondary Research Objectives:
To evaluate the interval of progression-free survival (iPFS) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
To evaluate other antitumor efficacy indicators in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine: progression-free survival (PFS), duration of response (DoR), and disease control rate (DCR).
To assess the safety (Safety) and the improvement of quality of life (QoL) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine.
To explore the impact of antipsychotic medication on the immune response to first-line immunotherapy in advanced NSCLC.
Study Design:
This study is an open-label, two-arm, multicenter, phase II randomized controlled study designed to evaluate and observe the impact of olanzapine on the efficacy of first-line immunotherapy in patients with advanced EGFR mutation-negative NSCLC. Eligible participants who meet all inclusion criteria and do not meet any exclusion criteria will receive first-line treatment with PD-1/PD-L1 monoclonal antibodies alone or in combination with chemotherapy (according to the instructions for use).
Study Subjects:
Ages 18 years and above (including 18) and up to 75 years (including 75); histologically or cytologically confirmed EGFR mutation-negative NSCLC; intended to receive first-line treatment with PD-1/PD-L1 inhibitors alone or in combination with chemotherapy.
Inclusion Criteria:
Participants voluntarily join this study and sign an informed consent form, with good compliance and cooperation with follow-up.
Age is 18 years and above (including 18) and up to 75 years (including 75). ECOG score: 0-2 points. Expected survival is no less than 3 months. Staged as Stage IV according to the TNM system. Confirmed to have NSCLC with EGFR mutation-negative by histology or cytology. Has not received systemic antitumor treatment, and is intended to receive first-line treatment with PD-1/PD-L1 inhibitors alone or in combination with chemotherapy.
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<1.5ULN; ALT and AST<2.5ULN; serum Cr≤1.25ULN or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula).
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.
Data Analysis/Statistical Methods:
Common Analysis This study will summarize the data using corresponding descriptive statistics according to the type of data, that is, for quantitative data, mean (Mean), standard deviation (SD), median (Median), minimum value (Minimum), and maximum value (Maximum) will be used, and for count data and grade data, frequency and percentage will be used, and time-event data will be estimated by the Kaplan-Meier method for the median time and the overall 95% confidence interval.
Efficacy Analysis The primary efficacy endpoint, the objective response rate (ORR) based on the investigator's assessment, will be compared between groups using the Fisher's exact probability test and the two-sided 95% confidence interval will be listed.
The secondary efficacy indicators, including the interval of progression-free survival (iPFS), progression-free survival (PFS), duration of response (DoR), and disease control rate (DCR), will be estimated using the Kaplan-Meier method for the median time and the median event and the two-sided 95% confidence interval will be listed, and the hazard ratio and its 95% confidence interval will be estimated. The disease control rate (DCR = CR + PR + SD) will be compared between groups using Fisher's exact probability test and the two-sided 95% confidence interval will be listed. Quality of life score statistical tests will use ANOVA or two-sided t-tests, and a P-value less than or equal to 0.05 will be considered statistically significant. Comparisons of changes before and after within groups will be made using paired t-tests.
Safety Analysis Safety analysis will mainly summarize descriptive statistics. Statistics will be summarized for adverse events (AEs) and treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory data, vital signs, etc. At the same time, statistical summaries will be made for the exposure to the study drug (including treatment cycles, total dose received, and dose intensity). The above data will be analyzed and summarized according to the current clinical trial reporting standards. Including: summary of adverse events (all causes and related to treatment); incidence and severity of adverse events (all causes and related to treatment); analysis of adverse events related to the drug; analysis of the outcome of adverse events; analysis of serious adverse events.
Sample Size Estimation:
This study is an open-label, two-arm, multicenter, phase II randomized controlled study. The primary research objective is to evaluate the objective response rate (ORR) in patients with advanced EGFR mutation-negative NSCLC treated with first-line PD-1/PD-L1 inhibitors combined with olanzapine. The study endpoint is the objective response rate (ORR) of the patients. Referring to historical literature, the ORR of first-line chemotherapy combined with immunotherapy in advanced NSCLC patients is about 50%, and it is expected that the combination with olanzapine can increase the ORR by 15%. After the first subject is enrolled, the longest observation period is 24 months, with α being two-sided 0.05, and the power being 90%, the study plans to enroll 156 subjects, with 78 in the experimental group and 78 in the control group, calculated with a 10% loss to follow-up rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment Group | Experimental | Drug: Olanzapine, Drug: NivolumabReceiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle.Then receive olanzapine orally at a dose of 5mg once daily (qd), with continuous administration for 6-8 weeks. |
| Group Without Olanzapine | Active comparator | Drug: NivolumabReceiving first-line treatment with a PD-1/PD-L1 inhibitor as a single agent or in combination with chemotherapy (according to the instructions manual)，Medication is administered on the first day of each cycle, with one cycle every 3 weeks. A continuous 21-day treatment constitutes one treatment cycle.. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants voluntarily enroll in this study and sign an informed consent form, with good compliance and cooperation with follow-up.
- Age is over 18 years old (including 18 years old) and under 75 years old (including 75 years old).
- ECOG score: 0-2 points.
- Expected survival is no less than 3 months.
- Staged as Stage IV according to the TNM system.
Key exclusion criteria (31 listed)
- Have received any of the following treatments:
- Subjects with concurrent other malignant tumors, except for basal cell carcinoma of the skin and in situ cancer.
- Subjects with uncontrollable malignant pleural effusion and pericardial effusion.
- Subjects allergic to contrast agents for CT and MRI or any subjects who cannot tolerate MRI examination.
- As judged by the investigator, any serious or poorly controlled systemic diseases, such as uncontrolled hypertension, active bleeding diathesis, or active infection.
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 |
|---|---|---|
| OlanzapineAlso: ZyprexaOlanzapine 5mg qd (once daily), q3w(every 3 weeks), oral therapy，Administered continuously for 6-8 weeks. | Drug | Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment Group |
| NivolumabAlso: OpdivoNivolumab，Infused intravenously once every 3 weeks at a dose of 2mg/kg, with a continuous 21-day treatment period constituting one treatment cycle. | Drug | Group Without Olanzapine, Olanzapine in Combination with Immune Checkpoint Inhibitors Treatment Group |
Primary outcome
The Overall Survival（OS）
Time frame: 24 months
The Overall Survival（OS），From the time of a patient's diagnosis or the commencement of treatment, to the time of the patient's death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 34385702Wang M, Herbst RS, Boshoff C. Toward personalized treatment approaches for non-small-cell lung cancer. Nat Med. 2021 Aug;27(8):1345-1356. doi: 10.1038/s41591-021-01450-2. Epub 2021 Aug 12.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Individual participant dataSharing planned: No
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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.
Lin Chuyang, Director study director
Nanchang University
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 Olanzapine and Nivolumab in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
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 9 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 5 May 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huang Long, Director (+86 13699549060, huanglongdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overall Survival（OS） (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554613, which also lists 2 linked publications.
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 5 May 2026.