Advanced or Metastatic Non-squamous Non-small-cell Lung CancerPhase 3NCT05132413
A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer
A Phase 3 study testing SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab in people with Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs 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 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 561 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2021to 30 Dec 2024
- Phase
- Phase 3
- 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
- -
- A subject must satisfy all of the following criteria to be considered for inclusion in the study:
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- Failed with prior EGFR-TKIs 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
- -
- A subject who meets any of the following criteria will be excluded from study entry:
- 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.
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- Inadequately controlled hypertension.
- Tumour infiltration into the great vessels on imaging.
- History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
- Uncontrolled tumour-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 Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
- Being tested
- SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab, Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin, Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumabDrug
SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatinDrug
Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatinDrug
Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab |
| Placebo group 1 | Placebo comparator | Not described Receives: Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin |
| Placebo group 2 | Placebo comparator | Not described Receives: Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
Measured: 2 years
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
Measured: 2 years
Secondary outcomes (12)
Progression free survival (PFS)（Stage I）
Measured: 2 years
Objective response rate (ORR)（Stage I）
Measured: 2 years
Disease control rate (DCR) （Stage I）
Measured: 2 years
Duration of response (DOR) （Stage I）
Measured: 2 years
Overall survival (OS) （Stage I）
Measured: 2 years
Progression free survival (PFS)（Stage II）
Measured: 2 years
Objective response rate (ORR)（Stage II）
Measured: 2 years
Disease control rate (DCR)（Stage II）
Measured: 2 years
Duration of response (DOR) （Stage II）
Measured: 2 years
Overall survival (OS) （Stage II）
Measured: 2 years
Incidence and severity of adverse events (AEs), serious adverse events （Stage II）
Measured: 2 years
(SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）
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 posted24 Nov 2021
- Study start30 Dec 2021 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 561 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
- NCT05132413
- Sponsor's protocol ID
- SHR-1701-III-310
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study of SHR-1701 in Combination With Bevacizumab and Chemotherapy in Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer With EGFR Mutation After Failure of TKIs
- ClinicalTrials.gov ID
- NCT05132413
- Acronym / sponsor ID
- SHR-1701-III-310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 561 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Nov 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.
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab |
| Placebo group 1 | Placebo comparator | Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin |
| Placebo group 2 | Placebo comparator | Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- A subject must satisfy all of the following criteria to be considered for inclusion in the study:
- Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
- Failed with prior EGFR-TKIs treatments.
- Measurable disease, as defined by RECIST v1.1
Key exclusion criteria (12 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.
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 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumabSHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab | Drug | treatment group |
| Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatinPlacebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin | Drug | Placebo group 1 |
| Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatinPlacebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin | Drug | Placebo group 2 |
Primary outcome
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）
Time frame: 2 years
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）
Time frame: 2 years
12 secondary outcomes
Progression free survival (PFS)（Stage I）
Time frame: 2 years
Objective response rate (ORR)（Stage I）
Time frame: 2 years
Disease control rate (DCR) （Stage I）
Time frame: 2 years
Duration of response (DOR) （Stage I）
Time frame: 2 years
Overall survival (OS) （Stage I）
Time frame: 2 years
Progression free survival (PFS)（Stage II）
Time frame: 2 years
Objective response rate (ORR)（Stage II）
Time frame: 2 years
Disease control rate (DCR)（Stage II）
Time frame: 2 years
Duration of response (DOR) （Stage II）
Time frame: 2 years
Overall survival (OS) （Stage II）
Time frame: 2 years
Incidence and severity of adverse events (AEs), serious adverse events （Stage II）
Time frame: 2 years
(SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）
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 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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 3 study testing SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab 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 8 inclusion and 12 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 24 Nov 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yuanchao Wang (0518-81220278, yuanchao.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I） (time frame: 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 24 Nov 2021.