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..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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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 groups in NCT04699968
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.

15 Jan 202115 Nov 2021

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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All Non-Small-Cell Lung Cancer trials

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.

Related trials for Non-Small-Cell Lung Cancer

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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?

On the ClinicalTrials.gov record for NCT04699968.

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.