Small Cell Lung Cancer Limited StagePhase 2NCT04189094
Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC
A Phase 2 study testing Sintilimab, Etoposide and Cisplatin in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer Hospital.
Trial summary
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Limited Stage
- What is being tested?
- Sintilimab, Etoposide and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed diagnosis of SCLC.
- Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
- Patients should be ≥ 18 years old.
- ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
- With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
- With weight loss no more than 10% within 6 months before diagnosis.
- Informed consent must be signed.
Who cannot join
- Histology confirmed the mixed NSCLC components;
- Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
- Any disease or condition contraindicated by radiotherapy or chemotherapy;
- Malignant pleural effusion and pericardial effusion;
- Pregnant and lactating women;
- History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
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- Received live vaccination within 28 days before the first administration of the study drug;
- 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.
- Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
- The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
- Conditions
- Small Cell Lung Cancer Limited Stage
- Being tested
- Sintilimab, Etoposide, Cisplatin, radiotherapy
- Keywords
- radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
EtoposideDrug
Also called VP-16
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
CisplatinDrug
Also called DDP
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
radiotherapyRadiation
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab + CRT arm | Experimental | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. Receives: Drug: Sintilimab; Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy |
| CRT arm | Active comparator | Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). Receives: Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
Measured: 2 years
Secondary outcomes (2)
Overall survival
OS, measured from the date of randomization to the date of death from any cause.
Measured: 5 years
Overall response rates
ORR, tumor response will be measured by using the RECIST 1.1.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Limited StageStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan
- Responsible party
- Sponsor
- Investigators
- Ming Chen, MD. PhD., Principal investigator, Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189094
- Sponsor's protocol ID
- IRB-2019-164
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT04189094
- Acronym / sponsor ID
- IRB-2019-164
- Conditions
- Small Cell Lung Cancer Limited Stage
- Keywords
- radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 6 Dec 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 study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab + CRT arm | Experimental | Drug: Sintilimab, Drug: Etoposide, Drug: Cisplatin, Radiation: radiotherapyPatients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. |
| CRT arm | Active comparator | Drug: Etoposide, Drug: Cisplatin, Radiation: radiotherapyPatients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/cytologically confirmed diagnosis of SCLC.
- Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
- Patients should be ≥ 18 years old.
- ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
- With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
Key exclusion criteria (10 listed)
- Histology confirmed the mixed NSCLC components;
- Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
- Any disease or condition contraindicated by radiotherapy or chemotherapy;
- Malignant pleural effusion and pericardial effusion;
- Pregnant and lactating women;
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 |
|---|---|---|
| SintilimabEtoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. | Drug | Sintilimab + CRT arm |
| EtoposideAlso: VP-16Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66. | Drug | CRT arm, Sintilimab + CRT arm |
| CisplatinAlso: DDPcisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64. | Drug | CRT arm, Sintilimab + CRT arm |
| radiotherapyThoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions). | Radiation | CRT arm, Sintilimab + CRT arm |
Primary outcome
Progression-free survival
Time frame: 2 years
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
2 secondary outcomes
Overall survival
Time frame: 5 years
Overall response rates
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
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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.
Ming Chen, MD. PhD. principal investigator
Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Etoposide and Cisplatin in people with Small Cell Lung Cancer Limited Stage, run by Zhejiang Cancer Hospital.
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 7 inclusion and 10 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ming Chen, MD. PhD. (86-571-88122199, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years). 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 6 Dec 2019.