Non-Small-Cell Lung CancerPhase 2NCT04699968
A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC
A Phase 2 study testing SHR-1701，Famitinib and SHR-1701 in people with Non-Small-Cell 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 with or without famitinib in patients with advanced or metastatic NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- SHR-1701，Famitinib and SHR-1701
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 15 Nov 2021
- 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
- voluntarily participate in the study and sign the informed consent form;
- 18 to 75 years old, both male and female;
- histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC
- one prior platinum-containing chemotherapy for advanced or metastatic disease;
- measurable lesions by RECIST v1.1;
- ECOG score: 0-1;
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- life expectancy ≥ 3 months;
- adequate hematological, hepatic and renal function;
- non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.
Who cannot join
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
- tumor infiltration into the great vessels on imaging;
- active CNS metastases;
- malignancies other than NSCLC within 5 years;
- anticancer therapy within 4 weeks before the start of trial treatment;
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- persisting toxicity related to prior therapy of Grade > 1;
- treatment with systemic immunostimulatory agents within 4 weeks;
- treatment with systemic immunosuppressive agents within 2 weeks;
- autoimmune diseases;
- interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;
- clinically significant cardiovascular or cerebrovascular diseases;
- inadequately controlled hypertension;
- history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;
- venous or arterial thrombosis within 6 months;
- evidence of bleeding diathesis or coagulopathy;
- use of anticoagulants or thrombolytic agents that has not been stable;
- active Tuberculosis infection;
- significant acute or chronic infections within 1 month;
- known history of testing positive test for HIV or known AIDS;
- hepatitis B virus or hepatitis C virus infection;
- allergic to any component of the treatment regimen;
- other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.
About this study
Official title: Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without famitinib in patients with advanced or metastatic NSCLC
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- SHR-1701，Famitinib, SHR-1701
- 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.
SHR-1701，FamitinibDrug
SHR -1701, Intravenous ；Famitinib, oral
SHR-1701Drug
SHR -1701, Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1701，Famitinib |
| Treatment group B | Experimental | Not described Receives: Drug: SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: determined by RECIST v1.1, up to approximately 1 year
Secondary outcomes (5)
PFS
Progression-Free-Survival
Measured: determined by RECIST v1.1, up to approximately 1 year
DCR
Disease Control Rate
Measured: determined by RECIST v1.1, up to approximately 1 year
DoR
Duration of Response
Measured: determined by RECIST v1.1, up to approximately 1 year
OS
Overall Survival
Measured: up to approximately 1 year
AEs+ SAEs
Adverse Events and Serious Adverse Events
Measured: determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Jan 2021 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Nov 2021 (estimated)
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell 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 with or without Famitinib
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT04699968
- Sponsor's protocol ID
- SHR-1701-Ⅱ-206
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jun 2023
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT04699968
- Acronym / sponsor ID
- SHR-1701-Ⅱ-206
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 7 Jan 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 with or without famitinib in patients with advanced or metastatic NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SHR-1701 with or without Famitinib
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1701，Famitinib |
| Treatment group B | 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 (9 listed)
- voluntarily participate in the study and sign the informed consent form;
- 18 to 75 years old, both male and female;
- histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC
- one prior platinum-containing chemotherapy for advanced or metastatic disease;
- measurable lesions by RECIST v1.1;
Key exclusion criteria (23 listed)
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
- tumor infiltration into the great vessels on imaging;
- active CNS metastases;
- malignancies other than NSCLC within 5 years;
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, Intravenous ；Famitinib, oral | Drug | Treatment group A |
| SHR-1701SHR -1701, Intravenous | Drug | Treatment group B |
Primary outcome
ORR
Time frame: determined by RECIST v1.1, up to approximately 1 year
Objective Response Rate
5 secondary outcomes
PFS
Time frame: determined by RECIST v1.1, up to approximately 1 year
DCR
Time frame: determined by RECIST v1.1, up to approximately 1 year
DoR
Time frame: determined by RECIST v1.1, up to approximately 1 year
OS
Time frame: up to approximately 1 year
AEs+ SAEs
Time frame: determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701，Famitinib and SHR-1701 in people with Non-Small-Cell 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 9 inclusion and 23 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: withdrawn, as of the sponsor's last update on 7 Jun 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ORR (time frame: determined by RECIST v1.1, 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 7 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.