Non-Small Cell Lung CancerPhase 2FLYFLYNCT04937972
SHR-1701 Combined With Fluzoparib in Lung Squamous Cell Carcinoma
A Phase 2 study testing SHR-1701 Combined With Fluazopalil in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
The purpose of the trial was to evaluate the efficacy and safety of SHR-1701 combined with fluzopar as a first-line treatment maintenance therapy for advanced lung squamous cell carcinoma. 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?
- SHR-1701 Combined With Fluazopalil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jun 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.The age at the time of signing the informed consent form is 18-75 years old, both male and female;
- 2.Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology;
- 3.Has not received systemic treatment for the recurrence or metastasis stage in the past. If you have received neoadjuvant or adjuvant chemotherapy/radiotherapy in the past, those who have relapsed or metastasized> 6 months from the end of treatment can be included in the group.
- 4.ECOG PS score: 0-1 points;
- 5.According to the RECIST 1.1 standard, the patient must have at least one measurable lesion;
- 6.The function of major organs is normal, that is, it meets the following standards: a) Routine blood examination (under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ) ≥1.5×109/L; platelet (PLT) ≥100×109/L; white blood cell count (WBC) ≥3.0×109/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ×Upper limit of normal (ULN); serum total bilirubin (TBIL)≤1.5×ULN; serum creatinine (Cr)≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
- 7.Expected survival period ≥ 3 months; Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, surgical sterilization should be performed Or agree to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
- 8.The patient voluntarily participates and signs the informed consent form (or signed by the legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.
Who cannot join
- 1) Untreated brain metastases (persons who have previously received treatment for brain metastases (radiotherapy or surgery), if the images have been confirmed to be stable for at least 4 weeks before randomization, and systemic hormone therapy has been discontinued (dose>10mg/day prednisone or Other equivalent hormones), those without clinical symptoms can be included in the group);
- 2) With meningeal metastasis, spinal cord compression, etc.;
- 3) Patients with pleural effusion, pericardial effusion or ascites who need to be drained with clinical symptoms, or who have received drainage of serous cavity effusion for treatment purposes within 2 weeks before randomization;
- 4) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection ；
- 5) Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma have been completely relieved and no intervention is required after adulthood or vitiligo can be included, and patients who require medical intervention with bronchodilators cannot be included;
- 6) Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration;
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- 7) Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- 8) Persons with a history of significant clinical significance of cardiovascular disease, including but not limited to; (1) Congestive heart failure (NYHA grade> 2); (2) Unstable angina pectoris; (3) 3 months before signing the ICF Myocardial infarction occurred within; (4) Any supraventricular arrhythmia or ventricular arrhythmia that requires treatment or intervention;
- 9) Suffered from or accompanied with other systemic malignancies in the last 5 years, (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- 10) Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first administration;
- 11) Those who are known to be allergic to any test drug or its excipients;
- 12) Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;
- 13) Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- 14) Patients who are unable to swallow the study drug, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction and other factors that affect drug intake and absorption;
- 15) Other situations that the researcher thinks are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
Official title: SHR-1701 Combined With Fluzoparib as Maintenance Therapy for Advanced Lung Squamous Cell Carcinoma After Platium Based Chemo-immunotherapy
The purpose of the trial was to evaluate the efficacy and safety of SHR-1701 combined with fluzopar as a first-line treatment maintenance therapy for advanced lung squamous cell carcinoma. Patients with advanced or metastatic (stage IV) lung squamous cell carcinoma have not received systemic chemotherapy and have measurable lesions (RECIST 1.1) ECOG PS 0-1. The patient received SHR1701 +fluzoparib
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SHR-1701 Combined With Fluazopalil
- 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.
SHR-1701 Combined With FluazopalilDrug
SHR-1701 +fluzoparib
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 Combined With fluzoparib | Experimental | Not described Receives: Drug: SHR-1701 Combined With Fluazopalil |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: 1 year
Secondary outcomes (2)
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Measured: 1 year
DCR
Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (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 CancerStudies 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
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937972
- Sponsor's protocol ID
- SHR-1701
- Acronym
- FLYFLY
- Status last verified
- Dec 2023
- First submitted
- 18 Jun 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1701 Combined With Fluzoparib as Maintenance Therapy for Advanced Lung Squamous Cell Carcinoma After Platium Based Chemo-immunotherapy
- ClinicalTrials.gov ID
- NCT04937972
- Acronym / sponsor ID
- FLYFLY / SHR-1701
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Jun 2021 (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.
The purpose of the trial was to evaluate the efficacy and safety of SHR-1701 combined with fluzopar as a first-line treatment maintenance therapy for advanced lung squamous cell carcinoma. Patients with advanced or metastatic (stage IV) lung squamous cell carcinoma have not received systemic chemotherapy and have measurable lesions (RECIST 1.1) ECOG PS 0-1. The patient received SHR1701 +fluzoparib
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 Combined With fluzoparib | Experimental | Drug: SHR-1701 Combined With Fluazopalil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.The age at the time of signing the informed consent form is 18-75 years old, both male and female;
- 2.Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology;
- 3.Has not received systemic treatment for the recurrence or metastasis stage in the past. If you have received neoadjuvant or adjuvant chemotherapy/radiotherapy in the past, those who have relapsed or metastasized> 6 months from the end of treatment can be included in the group.
- 4.ECOG PS score: 0-1 points;
- 5.According to the RECIST 1.1 standard, the patient must have at least one measurable lesion;
Key exclusion criteria (15 listed)
- 1) Untreated brain metastases (persons who have previously received treatment for brain metastases (radiotherapy or surgery), if the images have been confirmed to be stable for at least 4 weeks before randomization, and systemic hormone therapy has been discontinued (dose>10mg/day prednisone or Other equivalent hormones), those without clinical symptoms can be included in the group);
- 2) With meningeal metastasis, spinal cord compression, etc.;
- 3) Patients with pleural effusion, pericardial effusion or ascites who need to be drained with clinical symptoms, or who have received drainage of serous cavity effusion for treatment purposes within 2 weeks before randomization;
- 4) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection ；
- 5) Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma have been completely relieved and no intervention is required after adulthood or vitiligo can be included, and patients who require medical intervention with bronchodilators cannot be included;
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 |
|---|---|---|
| SHR-1701 Combined With FluazopalilSHR-1701 +fluzoparib | Drug | SHR-1701 Combined With fluzoparib |
Primary outcome
PFS
Time frame: 1 year
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
2 secondary outcomes
ORR
Time frame: 1 year
DCR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
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 SHR-1701 Combined With Fluazopalil in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital 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 8 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 29 Dec 2023. 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 Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). 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 29 Dec 2023.