Small Cell Lung CancerPhase 2NCT03983759
Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
A Phase 2 study testing sintilimab maintenance in people with Small Cell Lung Cancer and Extensive Disease, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy
- What is being tested?
- sintilimab maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2019to 31 May 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- small cell lung cancer confirmed by pathology
- extensive small cell lung cancer by imaging
- at least one measurable lesion by RECIST 1.1
- ECOG 0-1
- adequate organ function
- no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
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- no history of other maliganancies
- Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
- agreement to participate in the study and signed informed consent from the patients
Who cannot join
- serious infectious diseases four weeks before enrollment
- requirement intermittent use of bronchodilators or medical interventions;
- the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
- severe allergies
- severe mental disorders
- abnormal coagulation function
- previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
- other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
Quanli Gao, M.D, +86-371-65587795, gaoquanli2015@126.com
Lingdi Zhao, M.D., +86-371-65587483, lingdizhao@126.com
About this study
Official title: Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.
- Conditions
- Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy, Chemotherapy, Maintenance
- Being tested
- sintilimab maintenance
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimab maintenanceDrug
the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events.
the dose of sintilimab is fixed dose of 200mg every three weeks Receives: Drug: sintilimab maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
median survival time
the period from the day of enrollment to the date of death
Measured: two years.
Secondary outcomes (3)
progression-free survival
the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.
Measured: six months
objective response rate of sintilimab
from the date of first dose of sintilimab to the date of confirmed progression following
Measured: six month
adverse events rate of sintilimab
the rate of adverse events during the maintenance therapy of sintilimab
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start20 Jun 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Ding, Master, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983759
- Sponsor's protocol ID
- HenanCH immunotherapy002
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma B, Zhou Y, Shang Y, Zhang Y, Xu B, Fu X, Guo J, Yang Y, Zhang F, Zhou M, Huang H, Li F, Lin H, Zhao L, Wang Z, Gao Q. Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer. Front Oncol. 2022 Sep 9;12:852885. doi: 10.3389/fonc.2022.852885. eCollection 2022.
PubMed 36158690
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
- ClinicalTrials.gov ID
- NCT03983759
- Acronym / sponsor ID
- HenanCH immunotherapy002
- Conditions
- Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy, Chemotherapy, Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 12 Jun 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.
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: sintilimab maintenancephlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events. the dose of sintilimab is fixed dose of 200mg every three weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- small cell lung cancer confirmed by pathology
- extensive small cell lung cancer by imaging
- at least one measurable lesion by RECIST 1.1
- ECOG 0-1
- adequate organ function
Key exclusion criteria (8 listed)
- serious infectious diseases four weeks before enrollment
- requirement intermittent use of bronchodilators or medical interventions;
- the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
- severe allergies
- severe mental disorders
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 |
|---|---|---|
| sintilimab maintenancethe patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks. | Drug | treatment group |
Primary outcome
median survival time
Time frame: two years.
the period from the day of enrollment to the date of death
3 secondary outcomes
progression-free survival
Time frame: six months
objective response rate of sintilimab
Time frame: six month
adverse events rate of sintilimab
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 36158690Ma B, Zhou Y, Shang Y, Zhang Y, Xu B, Fu X, Guo J, Yang Y, Zhang F, Zhou M, Huang H, Li F, Lin H, Zhao L, Wang Z, Gao Q. Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer. Front Oncol. 2022 Sep 9;12:852885. doi: 10.3389/fonc.2022.852885. eCollection 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.
Jing Ding, Master principal investigator
Henan 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 sintilimab maintenance in people with Small Cell Lung Cancer and Extensive Disease, run by Henan Cancer 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 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 11 Jun 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 Quanli Gao, Dr. (+86-15038171966, gaoquanli2015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median survival time (time frame: two years.). 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 NCT03983759, which also lists 1 linked publication.
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 11 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.