Non-squamous Non-small Cell Lung CancerNCT04063449
Endostar/PD-1 Inhibitors Combined With PP for Advanced NSCLC
A study testing endostar/PD-1 inhibitor and endostar in people with Non-squamous Non-small Cell Lung Cancer, run by Dong Wang at 1 site in China.
Trial summary
A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With chemotherapy(Carboplatin-Pemetrexed) as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- endostar/PD-1 inhibitor and endostar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 30 Jun 2021
- Phase
- Interventional
- 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
- Patients volunteered to participate in the study and signed the informed consent;
- Age 18-75, both male and female;
- Histologically or cytologically confirmed advanced or metastatic (stage III B, III C or IV) non-squamous NSCLC , and no mutation was detected in the driving gene.
- At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
- ECOG PS 0-1
- Expected survival ≥ 3 months
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- Patients who never received systemic therapy in the past, including radiotherapy ,chemotherapy, targeted therapy and immunotherapy , or patients who relapsed more than 6 months after adjuvant chemotherapy.
- The main organ functions accorded with the following criteria within 7 days before treatment:
- (1)Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 109/L; platelet (PLT) ≥80 109/L.
- Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 *ULN, if accompanied by liver metastasis, ALT and AST ≤ 5* ULN; 3) serum creatinine (Cr) ≤ 1.5* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L).
- Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
- 9 Tissue samples should be provided for biomarker analysis (such as PD-L1 ) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation.
Who cannot join
- Severe allergic reactions to humanized antibodies or fusion proteins in the past
- known to have hypersensitivity to any component contained in Endostar or antibody preparations;
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent);
- Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
- Patients treated targeted drugs such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regiffenil, apatinib and anlotinib
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- Patients recieved systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping
- Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
- Patients with active pulmonary tuberculosis (TB) infection judged by chest X-ray examination, sputum examination and clinical physical examination. Patients with active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; Patients with active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously were appropriate.
- Patients with brain metastases with symptoms or symptoms controlling less than 2 months
- Major surgical treatment, incision biopsy or significant traumatic injury were performed within 28 days before the grouping.
- The imaging showed that the tumors had invaded important blood vessels or likely to invade important blood vessels and cause fatal massive hemorrhage during the follow-up period judged by researchers.
- patients with any physical signs or history of bleeding; Patients with any bleeding or bleeding events ≥ CTCAE grade 3,unhealed wounds, ulcers or fractures within 4 weeks before grouping
- Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism.
- The study is dangerous for patients judged by researcher, or patients who may affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Dong Wang, PH.D., 86-23-68757151, dongwang64@hotmail.com
Dong Wang, PH.D.
About this study
Official title: A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With PP as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With chemotherapy(Carboplatin-Pemetrexed) as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
Read the detailed description
This study was a controlled clinical trial.A total of 170 patients with pathologically confirmed non-squamous NSCLC would be enrolled.Patients were randomly divided into two groups, with 85 in the group A and 85 in the group B.The group A was treated with endostar,sintilimab and chemotherapy(carboplatin-pemetrexed).The group B was treated with endostar and chemotherapy(carboplatin-pemetrexed).The efficacy and safety would be evaluated.The progression-free survival and overall survival would be analyzed.This data of this study might provide a more effective treatment for non-squamous NSCLC.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- endostar/PD-1 inhibitor, endostar
- Keywords
- Non-squamous NSCLC；endostar;PD-1 inhibitor;chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endostar/PD-1 inhibitorDrug
Antiangiogenic therapy plus immunotherapy and chemotherapy
endostarDrug
Antiangiogenic therapy plus chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental:group A | Experimental | endostar,210 mg,CIV 72h,d1-d3; sintilimab,200mg,IV,d1; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1； 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar plus sintilimab for maintenance therapy until PD or intolerable toxicity ; Receives: Drug: endostar/PD-1 inhibitor |
| control:group B | Active comparator | endostar,210 mg,CIV 72h,d1-d3; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1； 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar for maintenance therapy until PD or intolerable toxicity ; Receives: Drug: endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause
Measured: approximately 36 months
overall survival (OS)
overall survival is defined as the time from randomization to death from any cause
Measured: approximately 36 months
Secondary outcomes (2)
objective response rate(ORR)
complete response(CR)+partial response(PR) according to RECIST 1.1
Measured: approximately 18 months
adverse event(AE)
adverse event according to NCI CTCAE V4.0
Measured: approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start20 Aug 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Wang, Third Military Medical University
- Investigators
- Dong Wang, PH.D, Principal investigator, Daping Hospital, Third Military Medical University, Chongqing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063449
- Sponsor's protocol ID
- ThirdMMU09
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With PP as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
- ClinicalTrials.gov ID
- NCT04063449
- Acronym / sponsor ID
- ThirdMMU09
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Keywords
- Non-squamous NSCLC；endostar;PD-1 inhibitor;chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Dong WangUniversity, hospital or other
- Study start
- 20 Aug 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 21 Aug 2019 (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.
A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With chemotherapy(Carboplatin-Pemetrexed) as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
Detailed description
This study was a controlled clinical trial.A total of 170 patients with pathologically confirmed non-squamous NSCLC would be enrolled.Patients were randomly divided into two groups, with 85 in the group A and 85 in the group B.The group A was treated with endostar,sintilimab and chemotherapy(carboplatin-pemetrexed).The group B was treated with endostar and chemotherapy(carboplatin-pemetrexed).The efficacy and safety would be evaluated.The progression-free survival and overall survival would be analyzed.This data of this study might provide a more effective treatment for non-squamous NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:group A | Experimental | Drug: endostar/PD-1 inhibitorendostar,210 mg,CIV 72h,d1-d3; sintilimab,200mg,IV,d1; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1； 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar plus sintilimab for maintenance therapy until PD or intolerable toxicity ; |
| control:group B | Active comparator | Drug: endostarendostar,210 mg,CIV 72h,d1-d3; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1； 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar for maintenance therapy until PD or intolerable toxicity ; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients volunteered to participate in the study and signed the informed consent;
- Age 18-75, both male and female;
- Histologically or cytologically confirmed advanced or metastatic (stage III B, III C or IV) non-squamous NSCLC , and no mutation was detected in the driving gene.
- At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
- ECOG PS 0-1
Key exclusion criteria (15 listed)
- Severe allergic reactions to humanized antibodies or fusion proteins in the past
- known to have hypersensitivity to any component contained in Endostar or antibody preparations;
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent);
- Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
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 |
|---|---|---|
| endostar/PD-1 inhibitorAntiangiogenic therapy plus immunotherapy and chemotherapy | Drug | Experimental:group A |
| endostarAntiangiogenic therapy plus chemotherapy | Drug | control:group B |
Primary outcome
progression-free survival(PFS)
Time frame: approximately 36 months
progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause
overall survival (OS)
Time frame: approximately 36 months
overall survival is defined as the time from randomization to death from any cause
2 secondary outcomes
objective response rate(ORR)
Time frame: approximately 18 months
adverse event(AE)
Time frame: approximately 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Dong Wang, PH.D principal investigator
Daping Hospital, Third Military Medical University, Chongqing,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endostar/PD-1 inhibitor and endostar in people with Non-squamous Non-small Cell Lung Cancer, run by Dong Wang 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 12 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 21 Aug 2019. 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.
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 Dong Wang, PH.D (86-23-68757181, dongwang64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: approximately 36 months). The study lists 2 primary outcomes in all. 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 21 Aug 2019.