Non-small Cell Lung Cancer MetastaticPhase 4NCT04331626
Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC
A Phase 4 study testing Gemcitabine Injectable Product in people with Non-small Cell Lung Cancer Metastatic, run by Henan Cancer Hospital.
Trial summary
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Gemcitabine Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the patient voluntarily participated in the study and signed the informed consent;
- advanced non-small cell lung cancer with negative driving gene confirmed by pathology has at least one measurable focus.
- in the last 6 months, chemotherapy failed;
- 18-70 years old; ECoG PS score 0-1; estimated survival time over 3 months;
- within 7 days before treatment, the main organ functions meet the following standards:
- blood routine examination standard (without blood transfusion within 14 days):
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- hemoglobin (HB) ≥ 90g / L;
- neutrophil absolute value (ANC) ≥ 1.5 × 109 / L;
- platelet (PLT) ≥ 80 × 109 / L
- biochemical examination shall meet the following standards:
- TBIL ≤ 1.5 times the upper limit of normal value (ULN);
- ALT and AST ≤ 2.5 × ULN, if with liver metastasis, ALT and AST ≤ 5 × ULN;
- Cr ≤ 1.5 × ULN or CCR ≥ 60ml / min;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).
- women of childbearing age shall agree to use contraceptive measures (such as IUD, contraceptive pill or condom) during the study and within 6 months after the end of the study; women of childbearing age shall agree to use contraceptive measures during the study and within 6 months after the end of the study (such as IUD, contraceptive pill or condom); women of childbearing age shall agree to use contraceptive measures during the study and 6 months after the end of the study if their pregnancy test is negative within 7 days before the study.
Who cannot join
- patients who have used PD-1 antibody of other companies before;
- with pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE Level 2 dyspnea);
- unresponsive toxic reactions higher than level 1 of CTC AE (4.0) caused by any previous treatment, excluding hair loss;
- patients with any serious and / or uncontrolled disease, including:
- patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTc ≥ 480ms) and congestive heart failure ≥ grade 2 (NYHA classification);
- active or uncontrollable severe infection (≥ CTC AE Level 2 infection);
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- renal failure needs hemodialysis or peritoneal dialysis;
- patients with any serious and / or uncontrolled disease, including:
- have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- poor control of diabetes mellitus (FBG > 10mmol / L);
- routine urine test indicated that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
- patients with epilepsy who need treatment;
- received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the group;
- those who have a history of psychoactive drug abuse and are unable to quit or have mental disorders;
- participated in clinical trials of other anti-tumor drugs within four weeks;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory Clinical Study of Low-dose Gemcitabine Combined With Nivolumab for Second-line and Higher-line Treatment of Driving Gene-negative Non-small Cell Lung Cancer
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field.
The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected.
Read more
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild.
This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was ORR, while secondary endpoints included DCR, PFS, and OS.
Read the detailed description
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field.
Conventional view holds that chemotherapeutic drugs work by directly killing tumor cells. In recent years, with the in-depth understanding of immunity, people have realized that the anti-cancer effect of chemotherapy drugs depends on the body's sound immune system, and chemotherapy drugs have been more and more recognized as an immune regulator. However, it should be noted that the combination of drugs may not achieve the desired results, or even the opposite.
The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected.
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild.
This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was objective efficiency (ORR), while secondary endpoints included disease control rate (DCR), disease-free progression (PFS), and overall survival (OS).
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Gemcitabine Injectable Product
- Keywords
- PD - 1 antibodies, Low-dose Gemcitabine, Non-small Cell Lung Cancer
- 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.
Gemcitabine Injectable ProductDrug
Also called nivolumab
Low dose chemotherapy drug combined with pd-1 antibody, Gemcitabine should be administered at 50% of the recommended dose, i.e. 500mg/m2, for 30 minutes by intravenous drip. Day 1 and day 8 administration.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Gemcitabine Combined With nivolumab | Experimental | Bristol-myers squibb (BMS) company's nivolumab injection liquid (trade name: odiwal). Recommended dosage: 3mg/kg, intravenously injected once every 2 weeks for 60 minutes. As long as clinical benefit is observed, continue treatment with this product for up to 6 courses. Gemcitabine hydrochloride injection from eli lilly. Use 50% of the recommended dose, i.e. 500mg/m2, intravenously for 30 minutes. Day 1 and day 8 administration. Depending on the patient's tolerance to gemcitabine, a reduced dose may be considered for each treatment cycle or one treatment cycle. Use for 1 year. If a Ⅲ magnitude of adverse reactions, it is necessary to permanently discontinued. Receives: Drug: Gemcitabine Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete and partial remission.
Measured: 3 months
Secondary outcomes (3)
Disease control rate
The percentage of patients with PR + Cr and SD after treatment in the number of evaluable cases, and the RECIST standard is at least 4 weeks.
Measured: 3 years
disease free progression
The time from the beginning of treatment to the occurrence (in any respect) progression or (for any reason) death of the tumor.
Measured: 3 years
overall survival
The time from the beginning of treatment to (for any reason) death. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zibing Wang, Doctor, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331626
- Sponsor's protocol ID
- 2019090507
- Status last verified
- Dec 2019
- First submitted
- 31 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Low-dose Gemcitabine Combined With Nivolumab for Second-line and Higher-line Treatment of Driving Gene-negative Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04331626
- Acronym / sponsor ID
- 2019090507
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- PD - 1 antibodies, Low-dose Gemcitabine, Non-small Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Apr 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 2 Apr 2020 (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.
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field.
The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected.
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild.
This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was ORR, while secondary endpoints included DCR, PFS, and OS.
Detailed description
In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field.
Conventional view holds that chemotherapeutic drugs work by directly killing tumor cells. In recent years, with the in-depth understanding of immunity, people have realized that the anti-cancer effect of chemotherapy drugs depends on the body's sound immune system, and chemotherapy drugs have been more and more recognized as an immune regulator. However, it should be noted that the combination of drugs may not achieve the desired results, or even the opposite.
The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected.
Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild.
This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was objective efficiency (ORR), while secondary endpoints included disease control rate (DCR), disease-free progression (PFS), and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose Gemcitabine Combined With nivolumab | Experimental | Drug: Gemcitabine Injectable ProductBristol-myers squibb (BMS) company's nivolumab injection liquid (trade name: odiwal). Recommended dosage: 3mg/kg, intravenously injected once every 2 weeks for 60 minutes. As long as clinical benefit is observed, continue treatment with this product for up to 6 courses. Gemcitabine hydrochloride injection from eli lilly. Use 50% of the recommended dose, i.e. 500mg/m2, intravenously for 30 minutes. Day 1 and day 8 administration. Depending on the patient's tolerance to gemcitabine, a reduced dose may be considered for each treatment cycle or one treatment cycle. Use for 1 year. If a Ⅲ magnitude of adverse reactions, it is necessary to permanently discontinued. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- the patient voluntarily participated in the study and signed the informed consent;
- advanced non-small cell lung cancer with negative driving gene confirmed by pathology has at least one measurable focus.
- in the last 6 months, chemotherapy failed;
- 18-70 years old; ECoG PS score 0-1; estimated survival time over 3 months;
- within 7 days before treatment, the main organ functions meet the following standards:
Key exclusion criteria (15 listed)
- patients who have used PD-1 antibody of other companies before;
- with pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE Level 2 dyspnea);
- unresponsive toxic reactions higher than level 1 of CTC AE (4.0) caused by any previous treatment, excluding hair loss;
- patients with any serious and / or uncontrolled disease, including:
- patients with any serious and / or uncontrolled disease, including:
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 |
|---|---|---|
| Gemcitabine Injectable ProductAlso: nivolumabLow dose chemotherapy drug combined with pd-1 antibody, Gemcitabine should be administered at 50% of the recommended dose, i.e. 500mg/m2, for 30 minutes by intravenous drip. Day 1 and day 8 administration. | Drug | Low-dose Gemcitabine Combined With nivolumab |
Primary outcome
Objective response rate (ORR)
Time frame: 3 months
The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete and partial remission.
3 secondary outcomes
Disease control rate
Time frame: 3 years
disease free progression
Time frame: 3 years
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- 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. This study is not recruiting at the moment.
Zibing Wang, Doctor study director
Henan Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gemcitabine Injectable Product in people with Non-small Cell Lung Cancer Metastatic, run by Henan Cancer Hospital.
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 15 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zibing Wang, Doctor (+8610 037165587483, zlyywzb2118@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2020.