Non-small Cell Lung CancerPhase 2NCT04303130

Camrelizumab Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous NSCLC

A Phase 2 study testing Camrelizumab in people with Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is a single-arm, prospective, multi-center clinical trial. designed to evaluate patients with stage IV inability to receive or refuse chemotherapy.Efficacy and safety of first-line treatment with Camrelizumab and Endo in advanced lung squamous cell carcinoma Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Camrelizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteChina
Study dates: 31 Dec 2019to 31 Dec 2022
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

Subjects >/= 18 years of age at the time of Informed Consent.
Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) have a histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 8th edition) , and the stage IIIB/IIIC SqNSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy.
.No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm, the short diameter of CT scan of the lymph node lesions > 15 mm).

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The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
Hemoglobin ≥ 9.0 g/dL (90 g/L)
Absolute neutrophil count ≥ 2× 109/L
Platelets ≥ 100× 109/L
Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); alkaline phosphatase ≤ 5 × ULN
Serum creatinine ≤ 1× ULN or creatinine clearance > 60 mL/minute (using Cockcroft/Gault formula)
Subject dosen't have unhealed wounds before enrollment.
Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-1210. Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barriermethods of contraception from screening through 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-1210.
Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Who cannot join

Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed.
Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. Subjects with uncontrolled hypertension.
Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function).
subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included .
Participants who had abnormal blood coagulation (INR>1.5 or PT> ULN+4s, and or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulation；

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Urine routine indicates urinary protein ≥ ++, or confirms that 24-hour urine protein is ≥1.0 g；
Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
The patient has severe infection within 4 weeks before first administration（such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, ≥38.5 °C
There was significant coughing blood and significant clinically significant bleeding symptoms or a clear tendency to hemorrhage in the first 2 months before enrollment (such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above at baseline, or suffering from vasculitis, etc.).
Serious Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 12 months before enrollment.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA ≥ 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function). And subjects with active tuberculosis.
History of severe hypersensitivity reactions to any component contained in Endostar or antibody preparation of Camrelizumab. And known to have severe allergic reactions to infusion reactions.
Any known mental illness or substance abuse that may have an impact on compliance with the test requirements;
There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

Jian Fang contact

HengWei Hu contact

China1 site, 1 recruiting

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, +86-010-88196459, bcht2_mj@163.com
HengWei Hu, +86-010-88196459
Recruiting

Other trials in China

About this study

Official title: Camrelizumab (SHR-1210) Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous Non-small Cell Lung Cancer (NSCLC)

Conditions: Non-small Cell Lung Cancer
Being tested: Camrelizumab
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.

CamrelizumabDrug
Also called Endostar
Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes (the overall infusion time including the flushing time is not shorter than 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance.
The combination regimen is a medication cycle every three weeks (21 days).

Study groups in NCT04303130
Study group	Role	What they receive
Camrelizumab (SHR-1210) Combined With Endostar	Experimental	Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days). Receives: Drug: Camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

PFS (Progression-Free survival)
From the date Into this study (signed ICF) to tumor progression or death for any
Measured: 1 Year
One year survival rate
Measured: 1 Year

Secondary outcomes (3)

ORR (Objective control rate)
The rate of CR and PR
Measured: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
DCR (Disease control rate)
the rate of CR, PR plus SD
Measured: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
DOR(Duration of response）
Cr or PR to the first assessment of PD or death from any cause
Measured: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 201931 Dec 2022

First posted10 Mar 2020
Study start31 Dec 2019
Primary completion31 Dec 2022 (estimated)
Study completion31 Dec 2022 (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.
More trials run by Peking University Cancer Hospital & InstituteThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04303130
Sponsor's protocol ID: SHR1210-CHEMO-BZ-201909
Status last verified: Mar 2020
First submitted: 21 Feb 2020
Last updated: 10 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Camrelizumab (SHR-1210) Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT04303130
Acronym / sponsor ID: SHR1210-CHEMO-BZ-201909
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 52 participants (estimated)
Lead sponsor: Peking University Cancer Hospital & InstituteUniversity, hospital or other
Collaborators: Peking University First Hospital, Peking University Third Hospital, Beijing Shijitan Hospital, Capital Medical University, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University People's Hospital
Study start: 31 Dec 2019 (actual)
Primary completion: 31 Dec 2022 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 10 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Camrelizumab (SHR-1210) Combined With Endostar	Experimental	Drug: CamrelizumabCarelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Subjects >/= 18 years of age at the time of Informed Consent.
Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) have a histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 8th edition) , and the stage IIIB/IIIC SqNSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy.
.No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Key exclusion criteria (15 listed)

Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed.
Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. Subjects with uncontrolled hypertension.
Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function).
subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not 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
CamrelizumabAlso: EndostarCarelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes (the overall infusion time including the flushing time is not shorter than 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days).	Drug	Camrelizumab (SHR-1210) Combined With Endostar

Primary outcome

PFS (Progression-Free survival)
Time frame: 1 Year
From the date Into this study (signed ICF) to tumor progression or death for any
One year survival rate
Time frame: 1 Year

3 secondary outcomes

ORR (Objective control rate)
Time frame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
DCR (Disease control rate)
Time frame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.
DOR(Duration of response）
Time frame: From the date Into this study (signed ICF) to tumor progression，assessed up to 36 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.

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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.

Jian Fang contact

HengWei Hu contact

Jian Fang principal investigator

Peking University Cancer Hospital & Institute

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 Camrelizumab in people with Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute 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 16 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 10 Mar 2020. 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 Jian Fang (+86-010-88196459, bch2_mg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (Progression-Free survival) (time frame: 1 Year). 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?

On the ClinicalTrials.gov record for NCT04303130.

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 10 Mar 2020.