Advanced or Metastatic Non-squamous Non-small Cell Lung CancerPhase 2NCT04974957
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
A Phase 2 study testing SHR-1701；BP102 in people with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- SHR-1701；BP102
- 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
- 30 Aug 2021to 30 Aug 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
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- Failed with prior systemic treatments.
- Measurable disease, as defined by RECIST v1.1
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 3 months
- Adequate hematologic and end-organ function as defined in the protocol
Who cannot join
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Symptomatic, untreated or active central nervous system metastases.
- Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
- With any active autoimmune disease or history of autoimmune disease.
- Inadequately controlled hypertension.
- Tumor infiltration into the great vessels on imaging.
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- History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
- Uncontrolled tumor-related pain.
- Patients with active hepatitis B or hepatitis C
- Severe infections within 4 weeks prior to initiation of study treatment.
- Active tuberculosis within one year prior to initiation of study treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.
- Being tested
- SHR-1701；BP102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701；BP102Drug
Drug: SHR-1701 IV infusion
Drug: BP102 IV infusion
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701+BP102 | Experimental | Not described Receives: Drug: SHR-1701；BP102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 2 years
Secondary outcomes (4)
Progression free survival (PFS)
Measured: 2 years
Disease control rate (DCR)
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start30 Aug 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974957
- Sponsor's protocol ID
- SHR-1701-II-207-LC
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 23 Jul 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
- ClinicalTrials.gov ID
- NCT04974957
- Acronym / sponsor ID
- SHR-1701-II-207-LC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 23 Jul 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 main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701+BP102 | Experimental | Drug: SHR-1701；BP102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- Failed with prior systemic treatments.
- Measurable disease, as defined by RECIST v1.1
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
- Life expectancy ≥ 3 months
Key exclusion criteria (11 listed)
- Histologically or cytologically confirmed mixed SCLC and NSCLC.
- Symptomatic, untreated or active central nervous system metastases.
- Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
- With any active autoimmune disease or history of autoimmune disease.
- Inadequately controlled hypertension.
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；BP102Drug: SHR-1701 IV infusion Drug: BP102 IV infusion | Drug | SHR-1701+BP102 |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
4 secondary outcomes
Progression free survival (PFS)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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；BP102 in people with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals 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 11 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 23 Jul 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 Hao Shen (+0518-82342973, hao.shen@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) (time frame: 2 years). 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 23 Jul 2021.