Extensive Stage Small Cell Lung CancerPhase 2NCT04790539
a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing SHR-1210 in people with Extensive Stage Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old
- Confirmed diagnosis of Extensive small cell lung cancer
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
- The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
- have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
- The estimated survival period is more than 8 weeks
- The subjects voluntarily joined the study, signed informed consent,
Who cannot join
- Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
- Leptomeningeal diseases
- Uncontrolled or symptomatic hypercalcemia
- Active, known or suspected autoimmune diseases
- have received any T cell co stimulation or immune checkpoint therapy
- Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
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- Subjects had active infections
- Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
- Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
- According to the researcher's judgment, there are other factors that may lead to the termination of the study
Trial locations and contacts
No sites are listed yet.
Caicun Zhou, PhD contact
Shengxiang Ren, PhD contact
About this study
Official title: an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- SHR-1210
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
Also called Anti-PD-1 Antibody
SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210+Paclitaxel-albumin+Carboplatin | Experimental | SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip. Receives: Drug: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS rate
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
Measured: up to 24 months
Secondary outcomes (4)
Overall Response Rate (ORR)
Determined using RECIST v1.1 criteria
Measured: Up to approximately 24 months
Progression-Free Survival(PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Measured: Up to approximately 24 months
Overall Survival(OS)
Defined as the time from randomization to death from any cause
Measured: Up to approximately 24 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 May 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 Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790539
- Sponsor's protocol ID
- ES-SCLC-1st-IIT-SHR1210-naP-CB
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04790539
- Acronym / sponsor ID
- ES-SCLC-1st-IIT-SHR1210-naP-CB
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Mar 2021 (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 project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive 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 |
|---|---|---|
| SHR-1210+Paclitaxel-albumin+Carboplatin | Experimental | Drug: SHR-1210SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years old
- Confirmed diagnosis of Extensive small cell lung cancer
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
- The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
- have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
Key exclusion criteria (10 listed)
- Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
- Leptomeningeal diseases
- Uncontrolled or symptomatic hypercalcemia
- Active, known or suspected autoimmune diseases
- have received any T cell co stimulation or immune checkpoint therapy
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 |
|---|---|---|
| SHR-1210Also: Anti-PD-1 AntibodySHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody | Drug | SHR-1210+Paclitaxel-albumin+Carboplatin |
Primary outcome
6-month PFS rate
Time frame: up to 24 months
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months
Progression-Free Survival(PFS)
Time frame: Up to approximately 24 months
Overall Survival(OS)
Time frame: Up to approximately 24 months
Number of Subjects with treatment-related adverse events (AEs)
Time frame: Up to approximately 24 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 2021.
- Individual participant dataSharing planned: 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.
Caicun Zhou, PhD contact
Shengxiang Ren, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1210 in people with Extensive Stage Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, 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 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 10 Mar 2021. 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 Caicun Zhou, PhD (caicunzhoudr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS rate (time frame: up to 24 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 10 Mar 2021.