Lung CancerPhase 2NCT04884009
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing SHR-1701； Famitinib and SHR-1701 in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- SHR-1701； Famitinib and SHR-1701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 31 May 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
- Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
- 18 to 75 years old, male or female.
- Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
- ECOG Performance Status of 0 or 1.
- Adequate hematological, hepatic and renal function.
- Female subjects of child-bearing potential must have a negative serum HCG test before treatment.
Who cannot join
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Untreated central nervous system metastases.
- Cancerous meningitis (meningeal metastasis).
- Uncontrolled pleural effusion, pericardial effusion or ascites.
- Tumor infiltration into the great vessels on imaging;
- Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
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- Uncontrolled tumor-related pain.
- Malignancies other than SCLC within 5 years.
- Systemic antitumor therapy was received 4 weeks prior to trial treatment.
- History of autoimmune diseases.
- Significant cardiovascular disease.
- Inadequately controlled hypertension.
- Known history of testing positive test for HIV or known AIDS.
- Patients with active hepatitis B or hepatitis C
- Severe infections within 4 weeks prior to trial treatment.
- Active tuberculosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy
- Conditions
- Lung Cancer
- Being tested
- SHR-1701； Famitinib, SHR-1701
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701； FamitinibDrug
SHR-1701+ Famitinib
SHR-1701Drug
SHR-1701
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701+ Famitinib | Experimental | Not described Receives: Drug: SHR-1701； Famitinib |
| SHR-1701 | Experimental | Not described Receives: Drug: SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) based on RECIST 1.1 criteria
Measured: up to approximately 1 year.
Secondary outcomes (5)
Progression free survival (PFS) based on RECIST 1.1 criteria
Measured: up to approximately 1 year.
Disease control rate (DCR) based on RECIST 1.1 criteria
Measured: up to approximately 1 year.
Duration of response (DoR)
Measured: up to approximately 1 year
Overall survival (OS)
Measured: up to approximately 1 year
AEs+ SAEs determined by NCI-CTCAE V5.0
Measured: Baseline until up to 90 days after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start31 May 2021 (estimated)
- Primary completion31 Dec 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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Model description
- SHR-1701 in combination with or without famitinib
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884009
- Sponsor's protocol ID
- SHR-1701-II-209
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
- ClinicalTrials.gov ID
- NCT04884009
- Acronym / sponsor ID
- SHR-1701-II-209
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SHR-1701 in combination with or without famitinib
| Arm | Type | Receives |
|---|---|---|
| SHR-1701+ Famitinib | Experimental | Drug: SHR-1701； Famitinib |
| SHR-1701 | Experimental | Drug: SHR-1701 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
- 18 to 75 years old, male or female.
- Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
- ECOG Performance Status of 0 or 1.
- Adequate hematological, hepatic and renal function.
Key exclusion criteria (16 listed)
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Untreated central nervous system metastases.
- Cancerous meningitis (meningeal metastasis).
- Uncontrolled pleural effusion, pericardial effusion or ascites.
- Tumor infiltration into the great vessels on imaging;
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-1701； FamitinibSHR-1701+ Famitinib | Drug | SHR-1701+ Famitinib |
| SHR-1701SHR-1701 | Drug | SHR-1701 |
Primary outcome
Objective response rate (ORR) based on RECIST 1.1 criteria
Time frame: up to approximately 1 year.
5 secondary outcomes
Progression free survival (PFS) based on RECIST 1.1 criteria
Time frame: up to approximately 1 year.
Disease control rate (DCR) based on RECIST 1.1 criteria
Time frame: up to approximately 1 year.
Duration of response (DoR)
Time frame: up to approximately 1 year
Overall survival (OS)
Time frame: up to approximately 1 year
AEs+ SAEs determined by NCI-CTCAE V5.0
Time frame: Baseline until up to 90 days after end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701； Famitinib and SHR-1701 in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
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 6 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 12 May 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 Wei Shi (021-68868570, wei.shi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) based on RECIST 1.1 criteria (time frame: up to approximately 1 year.). 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 12 May 2021.