Small Cell Lung CarcinomaPhase 2NCT04453930
A Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）
A Phase 2 study testing Camrelizumab，an engineered anti-PD-1 antibody, Platinum and Irinotecan in people with Small Cell Lung Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 [PD-1] ) in combination with Chemotherapy（Irinotecan plus Platinum）and with Apatinib (selective Vascular… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Camrelizumab，an engineered anti-PD-1 antibody, Platinum and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to Jun 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
- Extensive small cell lung cancer diagnosed by pathology or cytology.
- Patients with extensive stage small cell lung cancer who have not previously been treated for tumors (including radiotherapy, chemotherapy, use of similar VEGFR inhibitors and immune checkpoint inhibitors).
- The disease progress of the patients with limited SCLC who had received chemotherapy/radiotherapy before, and no further treatment more than 6 months after the last chemotherapy/radiotherapy.
- Expected survival≥3months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm)
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- The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria. a .Hemoglobin ≥ 9.0 g/dL (90 g/L) b .Absolute neutrophil count ≥ 1.5 x 109/L c .Platelets ≥ 100 x 109/L d .Total bilirubin (TBIL) ≤ 1 x upper limit of normal (ULN) e .Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x upper limit of normal(ULN); alkaline phosphatase ≤ 5 x ULN f .Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 45 mL/minute (using Cockcroft/Gault formula)
- Emale participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-1210. Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barriermethods of contraception from screening through 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-1210.
- Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Who cannot join
- 1.Imaging (CT or MRI) showed the presence of a central tumor that invades the local large vessels. Or there are obvious pulmonary cavitation or necrotizing tumors. 2. Patients with brain metastasis or meningeal metastasis.
- 3.Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
- 4.Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
- 5.Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria.
- 6.Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 7.Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function).
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- 8.Subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included .
- 9.Participants who had abnormal blood coagulation (INR>1.5 or PT> ULN+4s, and or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulation；Note: under the premise that the international standardized ratio of prothrombin time (INR) is ≤ 1.5, the use of low-dose heparin (60,000-12,000u per day for adults) or low-dose aspirin (≤ 100mg per day) is allowed for preventive purposes.
- 10.Urine routine indicates urinary protein ≥ ++, or confirms that 24-hour urine protein is ≥1.0 g.
- 11.Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture; 12.The patient has severe infection within 4 weeks before first administration（such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, ≥38.5 °.
- 13.There was significant coughing blood and significant clinically significant bleeding symptoms or a clear tendency to hemorrhage in the first 2 months before enrollment (such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above at baseline, or suffering from vasculitis, etc.).
- 14.Serious Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 12 months before enrollment.
- 15.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA ≥ 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function). And subjects with active tuberculosis.
- 16.Patients with a clear history of allergies may be potentially allergic to or intolerant to biological agents such as irinotecan, cisplatin, apatinib, and carillizumab; 17.There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months.
- 18.Any known mental illness or substance abuse that may have an impact on compliance with the test requirements.
- 19.There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Union Medical College Hospital
Beijing
Li Zhang, Ph.D, +8613911339836, zhanglipumch@aliyun.com
About this study
Official title: A Single-arm，Open Lable Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）
This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 [PD-1] ) in combination with Chemotherapy（Irinotecan plus Platinum）and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor [TKI]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + Apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Camrelizumab，an engineered anti-PD-1 antibody, Platinum, Irinotecan, Apatinib
- 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.
Camrelizumab，an engineered anti-PD-1 antibodyDrug
Also called SHR-1210
Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6) and maintenance phase (Cycle onward).
PlatinumDrug
Carboplatin： Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6).
Cisplatin： Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
IrinotecanDrug
Irinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
ApatinibDrug
Apatinib was administered at a dose of 250 mg during the maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib | Experimental | Participants received intravenous infusions of Camrelizumab 200 mg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) or Cisplatin 30 milligrams per square meter (mg/m^2) followed by Irinotecan 65 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4/5/6). On Days 8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6), Cisplatin 30 mg/m^2 and Irinotecan 65 mg/m^2 was administered. Thereafter, participants received maintenance (Cycle onward) Camrelizumab 200 mg on Day 1 of every 21-day cycle with Apatinib 250mg until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor. Receives: Drug: Camrelizumab，an engineered anti-PD-1 antibody; Drug: Platinum; Drug: Irinotecan; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as assessed by RECIST 1.1
PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Duration of Overall Survival (OS)
OS is defined as the time from date of enrollment to date of death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Secondary outcomes (3)
Disease Control Rate (DCR) as assessed by RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Measured: through study completion, an average of 2 year.
Objective Response Rate (ORR) as assessed by RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response(CR) or a Partial Response(PR) per RECIST 1.1.
Measured: through study completion, an average of 2 year.
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Measured: through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start8 Jun 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 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 CarcinomaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453930
- Sponsor's protocol ID
- HS-2195
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- 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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm，Open Lable Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）
- ClinicalTrials.gov ID
- NCT04453930
- Acronym / sponsor ID
- HS-2195
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Jul 2020 (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 single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 [PD-1] ) in combination with Chemotherapy（Irinotecan plus Platinum）and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor [TKI]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + Apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib | Experimental | Drug: Camrelizumab，an engineered anti-PD-1 antibody, Drug: Platinum, Drug: Irinotecan, Drug: ApatinibParticipants received intravenous infusions of Camrelizumab 200 mg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) or Cisplatin 30 milligrams per square meter (mg/m^2) followed by Irinotecan 65 mg/m^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4/5/6). On Days 8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6), Cisplatin 30 mg/m^2 and Irinotecan 65 mg/m^2 was administered. Thereafter, participants received maintenance (Cycle onward) Camrelizumab 200 mg on Day 1 of every 21-day cycle with Apatinib 250mg until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Extensive small cell lung cancer diagnosed by pathology or cytology.
- Patients with extensive stage small cell lung cancer who have not previously been treated for tumors (including radiotherapy, chemotherapy, use of similar VEGFR inhibitors and immune checkpoint inhibitors).
- The disease progress of the patients with limited SCLC who had received chemotherapy/radiotherapy before, and no further treatment more than 6 months after the last chemotherapy/radiotherapy.
- Expected survival≥3months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (16 listed)
- 1.Imaging (CT or MRI) showed the presence of a central tumor that invades the local large vessels. Or there are obvious pulmonary cavitation or necrotizing tumors. 2. Patients with brain metastasis or meningeal metastasis.
- 3.Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
- 4.Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
- 5.Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria.
- 6.Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
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 |
|---|---|---|
| Camrelizumab，an engineered anti-PD-1 antibodyAlso: SHR-1210Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6) and maintenance phase (Cycle onward). | Drug | Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib |
| PlatinumCarboplatin： Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6). Cisplatin： Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6). | Drug | Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib |
| IrinotecanIrinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6). | Drug | Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib |
| ApatinibApatinib was administered at a dose of 250 mg during the maintenance phase. | Drug | Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib |
Primary outcome
Progression-free Survival (PFS) as assessed by RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.
Duration of Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
OS is defined as the time from date of enrollment to date of death from any cause.
3 secondary outcomes
Disease Control Rate (DCR) as assessed by RECIST 1.1
Time frame: through study completion, an average of 2 year.
Objective Response Rate (ORR) as assessed by RECIST 1.1
Time frame: through study completion, an average of 2 year.
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Time frame: through study completion, an average of 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- 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.
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 Camrelizumab，an engineered anti-PD-1 antibody, Platinum and Irinotecan in people with Small Cell Lung Carcinoma, 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 9 inclusion and 16 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 1 Jul 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 Li Zhang, Ph.D (+8613911339836, zhanglipumch@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) as assessed by RECIST 1.1 (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.). The study lists 2 primary outcomes in all. 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 1 Jul 2020.