Carcinoma, Non-Small-Cell LungPhase 2NCT05603013
Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)
A Phase 2 study testing Vinorelbine, Radiotherapy and PD-1/PD-L1 inhibitor in people with Carcinoma, Non-Small-Cell Lung and Carcinoma Breast, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma Breast
- What is being tested?
- Vinorelbine, Radiotherapy and PD-1/PD-L1 inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 17 Oct 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and above;
- Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant non-small cell lung cancer and breast cancer patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
- ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
- Life expectancy greater than 3 months;
- T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0*ULN, or AST and ALT≤5*ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN#
- Signed informed consent form# -
Who cannot join
- 1. Current pregnancy or lactation# 2. History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous system diseases or mental illness; 4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosis infection; 10. Other disorders with clinical significance according to the researcher's judgment.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer (PRaG 6.0)
This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma Breast
- Being tested
- Vinorelbine, Radiotherapy, PD-1/PD-L1 inhibitor, GM-CSF, IL-2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Vinorelbine Tartrate Oral
RadiotherapyRadiation
hypofractionated radiotherapy
PD-1/PD-L1 inhibitorDrug
PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
GM-CSFDrug
GM-CSF subcutaneous injection
IL-2Drug
IL-2 subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 | Experimental | Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 Receives: Drug: Vinorelbine; Radiation: Radiotherapy; Drug: PD-1/PD-L1 inhibitor; Drug: GM-CSF; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate #ORR#
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Measured: 24 months
Secondary outcomes (4)
Progression-free Survival (PFS)
PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
Measured: 24 months
Disease control rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
Measured: 24 months
Overall survival (OS)
OS was defined as the time from the first administration of study treatment to death from any cause.
Measured: 24 months
Adverse event
rate of adverse events
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 posted2 Nov 2022
- Study start30 Oct 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion17 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603013
- Sponsor's protocol ID
- JD-LK-2022-136-01
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer (PRaG 6.0)
- ClinicalTrials.gov ID
- NCT05603013
- Acronym / sponsor ID
- JD-LK-2022-136-01
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 17 Oct 2024 (estimated)
- First posted
- 2 Nov 2022 (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.
This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 | Experimental | Drug: Vinorelbine, Radiation: Radiotherapy, Drug: PD-1/PD-L1 inhibitor, Drug: GM-CSF, Drug: IL-2Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years and above;
- Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant non-small cell lung cancer and breast cancer patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
- ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
- Life expectancy greater than 3 months;
- T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0*ULN, or AST and ALT≤5*ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN#
Key exclusion criteria (2 listed)
- 1. Current pregnancy or lactation# 2. History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous system diseases or mental illness; 4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosis infection; 10. Other disorders with clinical significance according to the researcher's judgment.
- -
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 |
|---|---|---|
| VinorelbineVinorelbine Tartrate Oral | Drug | Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
| Radiotherapyhypofractionated radiotherapy | Radiation | Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
| PD-1/PD-L1 inhibitorPD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection | Drug | Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
| GM-CSFGM-CSF subcutaneous injection | Drug | Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
| IL-2IL-2 subcutaneous injection | Drug | Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 |
Primary outcome
Objective Response Rate #ORR#
Time frame: 24 months
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Adverse event
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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.
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 Vinorelbine, Radiotherapy and PD-1/PD-L1 inhibitor in people with Carcinoma, Non-Small-Cell Lung and Carcinoma Breast, run by Second Affiliated Hospital of Soochow 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 6 inclusion and 2 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 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Zhang (0512-67784829, zhangliyuan126@126.com), 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: 24 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 Nov 2022.