Carcinoma, Non-Small Cell LungPhase 2STARNCT04167657
SinTilimab After Radiation (STAR Study)
A Phase 2 study testing Sintilimab in people with Carcinoma, Non-Small Cell Lung, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2019to 30 Apr 2024
- 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
- Signed written informed consent;
- Age ≥ 18 years ;
- Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;
- Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease or chemotherapy intolerant patients;
- Patients must have disease progression or recurrence after receiving first/second line systemic therapy for advanced or metastasis disease, or patients with chemotherapy intolerance during chemotherapy: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients with locally advanced disease treated with platinum-based adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and tumor recurrence ( local or metastatic ) within 6 months after completion of treatment are suitable for inclusion; 3) Subjects who relapsed more than 6 months after receiving platinum-based adjuvant, neoadjuvant therapy or radical chemoradiotherapy for locally advanced disease, and then progressed during or after receiving systemic treatment for recurrent tumors were suitable for inclusion; 4) Patients who received platinum-based double-drug chemotherapy after progression or chemotherapy intolerance were considered as second-line patients after first-line treatment; 5) After the progression of platinum-containing double-drug chemotherapy, patients who progressed again with a single-drug chemotherapy regimen or chemotherapy intolerance were considered as third-line patients after second-line treatment.
- ECOG PS 0-1, with expected survival over 3 months;
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- Patients shall have at least one leision eligible for radiation, e.g. bone metastasis, intrapulmonary node, adrenal disease, etc. Patient must have at least one disease (other than radiation target) according to RECIST 1.1: 1) Patient must have received radiation for 1 location after disease progression or recurrence after first line treatment for advanced or metastasis disease, the biological dose of a single site of radiotherapy is required to exceed 30 Gy ( 6 Gy × 5, or other ) or the plan can reach 30 Gy. 2) Radiotherapy can be performed on the same day as Sindilizumab, but the last radiotherapy is no more than 3 weeks after the start of Sindilizumab treatment.
- Adequate marrow and organ function as per baseline CBC/CMP/Urine test;
- Prior systemic anti-tumor therapy should be completed at least 4 weeks before enrollment, and adverse events of prior treatment shall be return to ≤G1 per CTCAE (except for alopecic or any non-clinical significant laboratory abnormalities) ;
- Women with childbearing potential or men whose female partners are with childbearing potential must agree to use efficient contraceptive methods during the study treatment period until 90 days after last dose of study treatment.
Who cannot join
- Previously treated by any immune therapy;
- Active infection including HBV, HCV, and HIV;
- Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;
- Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;
- Active or autoimmune disease;
- ILD, including drug-induced ILD, radiation pneumonia that required corticosteroids, or any clinical implication for active ILD;
- Any course that lead to treatment with continuous systemic corticosteroids >10 mg/day prednisone or equivalent dose of other steroids;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Respiratory Medicine, Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730
About this study
Official title: A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC
This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- Sintilimab
- Keywords
- Advanced non-small cell lung cancer, Immunotherapy, Radiation, PD-1, Sintilimab
- 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.
SintilimabDrug
Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 24 months.
Before enrollment, patient should undergo radiation no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Sintilimab shall be started no later than 3 weeks after radiation. Radiotherapy can be performed on the same day as sintilimab.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Sintilimab monotherapy every 3 weeks, after a radiation targeting a single location no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons
Measured: Time Frame: up to 12 months after enrollment or study close
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start15 Apr 2019
- Primary completion30 Nov 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
- Investigators
- Mengzhao Wang, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167657
- Sponsor's protocol ID
- HS-1856
- Acronym
- STAR
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC
- ClinicalTrials.gov ID
- NCT04167657
- Acronym / sponsor ID
- STAR / HS-1856
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- Advanced non-small cell lung cancer, Immunotherapy, Radiation, PD-1, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Nov 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.
This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: SintilimabSintilimab monotherapy every 3 weeks, after a radiation targeting a single location no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent;
- Age ≥ 18 years ;
- Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;
- Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease or chemotherapy intolerant patients;
- Patients must have disease progression or recurrence after receiving first/second line systemic therapy for advanced or metastasis disease, or patients with chemotherapy intolerance during chemotherapy: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients with locally advanced disease treated with platinum-based adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and tumor recurrence ( local or metastatic ) within 6 months after completion of treatment are suitable for inclusion; 3) Subjects who relapsed more than 6 months after receiving platinum-based adjuvant, neoadjuvant therapy or radical chemoradiotherapy for locally advanced disease, and then progressed during or after receiving systemic treatment for recurrent tumors were suitable for inclusion; 4) Patients who received platinum-based double-drug chemotherapy after progression or chemotherapy intolerance were considered as second-line patients after first-line treatment; 5) After the progression of platinum-containing double-drug chemotherapy, patients who progressed again with a single-drug chemotherapy regimen or chemotherapy intolerance were considered as third-line patients after second-line treatment.
Key exclusion criteria (8 listed)
- Previously treated by any immune therapy;
- Active infection including HBV, HCV, and HIV;
- Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;
- Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;
- Active or autoimmune 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 |
|---|---|---|
| SintilimabSintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 24 months. Before enrollment, patient should undergo radiation no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Sintilimab shall be started no later than 3 weeks after radiation. Radiotherapy can be performed on the same day as sintilimab. | Drug | Arm1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Time Frame: up to 12 months after enrollment or study close
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. 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.
Mengzhao Wang, M.D. principal investigator
Peking Union Medical College 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 in people with Carcinoma, Non-Small Cell Lung, run by Peking Union Medical College 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 10 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Time Frame: up to 12 months after enrollment or study close). 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 19 Sep 2024.