Staging IV NSCLCPhase 2NCT04094909
Rh-endostatin Combined With Chemotherapy and Pembrolizumab for Advanced NSCLC
A Phase 2 study testing Rh-endostatin in people with Staging IV NSCLC, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
The aim of this study was to investigate that efficacy and safety of rh-endostatin（Endostar）combined with platinum-based doublet chemotherapy and Pembrolizumab as first line therapy in patients with advanced or metastatic non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Staging IV NSCLC
- What is being tested?
- Rh-endostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2020to 31 Mar 2023
- 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
- Sign informed consent.
- Patients aged 18 to 75.
- According to the TNM staging of lung cancer in the 8th edition of the International Association for Lung Cancer Research and the Joint Committee on Cancer Classification of the United States, NSCLC with local advanced or metastatic stage (stage III B, III C or IV) confirmed by histology or cytology can not be treated surgically and can not be accepted by radical concurrent radiotherapy and chemotherapy.
- There must be at least one measurable lesion.
- ECOG PS was 0-1.
- NSCLC with driving gene was negative.
Show all 9Show fewer
- Patients who had not received systemic radiotherapy or chemotherapy before or who had relapsed more than 6 months after the end of adjuvant chemotherapy were followed up.
- Patient's survival more than 3months.
- The liver and kidney function is normal.
Who cannot join
- The subjects had cancerous meningitis.
- Patients with active central nervous system (CNS) metastasis should be excluded. If the patients with CNS metastasis can be adequately treated and the neurological symptoms of the subjects can be restored to baseline level at least two weeks before enrollment (except for residual signs or symptoms related to CNS treatment), who can be participated in the study. In addition, patients who do not use corticosteroids, or receive prednisone (or equivalent) at a steady or decreasing dose of less than 10 mg/day.
- Patients with active, known or suspected autoimmune diseases were excluded. Patients with type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (e.g., vitiligo, psoriasis or alopecia), or who are not expected to reappear without external triggers may be included.
- Within 14 days before admission, subjects requiring systemic corticosteroids (dose equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs were included. Patients who used inhaled or topical corticosteroids, and those who received corticosteroid replacement therapy at doses equal to more than 10 mg of prednisone per day, could participate in the study if there were no active autoimmune diseases.
- Hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab) are positive, indicating acute or chronic infection.
- According to chest X-ray examination, sputum examination and clinical examination, active pulmonary tuberculosis (TB) infection was judged. Patients with a history of active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously used are proved to be appropriate.
- Previous serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and intractable hypertension.
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhou Chengzhi
Guangzhou, Guangdong, 510120
Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com
About this study
Official title: Efficacy and Safety of Rh-endostatin（Endostar）Combined With Platinum-based Doublet Chemotherapy and Pembrolizumab as First Line Therapy in Patients With Advanced or Metastatic Non-small-cell Lung Cancer
The aim of this study was to investigate that efficacy and safety of rh-endostatin（Endostar）combined with platinum-based doublet chemotherapy and Pembrolizumab as first line therapy in patients with advanced or metastatic non-small-cell lung cancer.
Read the detailed description
The study design is a single arm. The subjects are 186, including Squamous and Non-Squamous NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and [nab]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous NSCLC, rh-endostatin at a dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles. The radiographic evaluation will be taken place at baseline, 6 and 12 weeks after treatment and every 9 weeks thereafter based on Recist 1.1, till to PD or unacceptable toxicities. After that, survival follow-up is going on every 3 months till to the death. The safety evaluation is based on CTCAE 4.0. In addition to the above, the examination of ct DNA and PD-L1 for tumor sample and peripheral blood is taken at the baseline, and also examination of ct DNA and PD-L1 for peripheral blood at week 6 and 12 of treatment and at the time of PD.
Primary endpoint: .PFS Secondary endpoints:OS,ORR,DCR and safety
- Conditions
- Staging IV NSCLC
- Being tested
- Rh-endostatin
- Keywords
- rh-endostatin, Pembrolizumab, NSCLC, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rh-endostatinDrug
Also called Pembrolizumab, carboplatin, cisplatin, pemetrexed
Squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +[nab]-paclitaxel during the treatment. Rh-endostatin+Pembrolizumab during the maintenance period.
Non-squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +pemetrexed during the treatment. Rh-endostatin+Pembrolizumab + pemetrexed during the maintenance period.
| Study group | Role | What they receive |
|---|---|---|
| Rh-endostatin + chemotherapy+Pembrolizumab | Experimental | The subjects are 186, including Squamous and Non-Squamous NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and [nab]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous NSCLC, rh-endostatin at dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles. Receives: Drug: Rh-endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
from the enrolment to PD or death
Measured: 6-10 months
Secondary outcomes (1)
OS
from the enrolment to death
Measured: 14-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start6 Feb 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staging IV NSCLCStudies 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
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Likun Chen, professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094909
- Sponsor's protocol ID
- CROC1902
- Status last verified
- Feb 2020
- First submitted
- 17 Sep 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rh-endostatin（Endostar）Combined With Platinum-based Doublet Chemotherapy and Pembrolizumab as First Line Therapy in Patients With Advanced or Metastatic Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04094909
- Acronym / sponsor ID
- CROC1902
- Conditions
- Staging IV NSCLC
- Keywords
- rh-endostatin, Pembrolizumab, NSCLC, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 6 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 19 Sep 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.
The aim of this study was to investigate that efficacy and safety of rh-endostatin（Endostar）combined with platinum-based doublet chemotherapy and Pembrolizumab as first line therapy in patients with advanced or metastatic non-small-cell lung cancer.
Detailed description
The study design is a single arm. The subjects are 186, including Squamous and Non-Squamous NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and [nab]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous NSCLC, rh-endostatin at a dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles. The radiographic evaluation will be taken place at baseline, 6 and 12 weeks after treatment and every 9 weeks thereafter based on Recist 1.1, till to PD or unacceptable toxicities. After that, survival follow-up is going on every 3 months till to the death. The safety evaluation is based on CTCAE 4.0. In addition to the above, the examination of ct DNA and PD-L1 for tumor sample and peripheral blood is taken at the baseline, and also examination of ct DNA and PD-L1 for peripheral blood at week 6 and 12 of treatment and at the time of PD.
Primary endpoint: .PFS Secondary endpoints:OS,ORR,DCR and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rh-endostatin + chemotherapy+Pembrolizumab | Experimental | Drug: Rh-endostatinThe subjects are 186, including Squamous and Non-Squamous NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and [nab]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous NSCLC, rh-endostatin at dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign informed consent.
- Patients aged 18 to 75.
- According to the TNM staging of lung cancer in the 8th edition of the International Association for Lung Cancer Research and the Joint Committee on Cancer Classification of the United States, NSCLC with local advanced or metastatic stage (stage III B, III C or IV) confirmed by histology or cytology can not be treated surgically and can not be accepted by radical concurrent radiotherapy and chemotherapy.
- There must be at least one measurable lesion.
- ECOG PS was 0-1.
Key exclusion criteria (8 listed)
- The subjects had cancerous meningitis.
- Patients with active central nervous system (CNS) metastasis should be excluded. If the patients with CNS metastasis can be adequately treated and the neurological symptoms of the subjects can be restored to baseline level at least two weeks before enrollment (except for residual signs or symptoms related to CNS treatment), who can be participated in the study. In addition, patients who do not use corticosteroids, or receive prednisone (or equivalent) at a steady or decreasing dose of less than 10 mg/day.
- Patients with active, known or suspected autoimmune diseases were excluded. Patients with type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (e.g., vitiligo, psoriasis or alopecia), or who are not expected to reappear without external triggers may be included.
- Within 14 days before admission, subjects requiring systemic corticosteroids (dose equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs were included. Patients who used inhaled or topical corticosteroids, and those who received corticosteroid replacement therapy at doses equal to more than 10 mg of prednisone per day, could participate in the study if there were no active autoimmune diseases.
- Hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab) are positive, indicating acute or chronic infection.
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 |
|---|---|---|
| Rh-endostatinAlso: Pembrolizumab, carboplatin, cisplatin, pemetrexedSquamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +[nab]-paclitaxel during the treatment. Rh-endostatin+Pembrolizumab during the maintenance period. Non-squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +pemetrexed during the treatment. Rh-endostatin+Pembrolizumab + pemetrexed during the maintenance period. | Drug | Rh-endostatin + chemotherapy+Pembrolizumab |
Primary outcome
PFS
Time frame: 6-10 months
from the enrolment to PD or death
1 secondary outcome
OS
Time frame: 14-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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.
Likun Chen, professor principal investigator
Sun Yat-sen University
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 Rh-endostatin in people with Staging IV NSCLC, run by Guangzhou Institute of Respiratory Disease 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 9 inclusion and 8 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 7 Feb 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 Chengzhi Zhou, professor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 6-10 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 7 Feb 2020.