Non-Small-Cell Lung CancerPhase 2NCT04560244
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment
A Phase 2 study testing SHR1701 in people with Non-Small-Cell Lung Cancer, run by Shandong Cancer Hospital and Institute.
Trial summary
This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. 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?
- SHR1701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 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
- Subjects voluntarily participate in this study and sign informed consent.
- NSCLC in stage IV.
- No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
- Previously received more than 1 chemotherapy regimen and progressed/ recurred.
- At least one lesion is suitable for hypofraction radiotherapy.
- There is at least one measurable lesion.
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- 18 to 75 years old
- ECOG 0-1
- The function of vital organs meets the following requirements. ANC ≥ 1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min#
- The estimated survival period is more than 3 months.
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment
Who cannot join
- The subjects had any history of autoimmune disease or active autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central squamous cell lung carcinoma.
- Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
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- Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
- Failing to properly control the clinical symptoms or disease of the heart.
- Subjects had active infections.
- Subjects may receive other systemic antitumor therapy during the study period.
- Other clinical trials of drugs were used in the first four weeks of the first medication.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Director of Shandong Cancer Hospital and Institute
This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- SHR1701
- Keywords
- SHR1701,radiotherapy,NSCLC
- 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.
SHR1701Drug
PD-L1 / TGF-β RII double antibody
| Study group | Role | What they receive |
|---|---|---|
| SHR 1701+radiotherapy | Experimental | SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy Receives: Drug: SHR1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse event (AE)
Measured: From the first administration of shr-1701 to 90 days after the last Administration
Number of participants experiencing serious adverse event (SAE)
Measured: From the first administration of shr-1701 to 90 days after the last Administration
Secondary outcomes (4)
progression-free survival （PFS）
Measured: Up to approximately 24 months
Objective Response Rate （ORR）
Measured: Up to approximately 24 months
Disease control rate (DCR)
Measured: Up to approximately 24 months
Overall survival (OS)
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- JinMing Yu, PhD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560244
- Sponsor's protocol ID
- NSCLC-2nd-IIT-SHR1701-RT
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director of Shandong Cancer Hospital and Institute
- ClinicalTrials.gov ID
- NCT04560244
- Acronym / sponsor ID
- NSCLC-2nd-IIT-SHR1701-RT
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- SHR1701,radiotherapy,NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Sep 2020 (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.
This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.
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+radiotherapy | Experimental | Drug: SHR1701SHR-1701 Simultaneously Combined with High Fractionation and Low-dose Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily participate in this study and sign informed consent.
- NSCLC in stage IV.
- No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
- Previously received more than 1 chemotherapy regimen and progressed/ recurred.
- At least one lesion is suitable for hypofraction radiotherapy.
Key exclusion criteria (11 listed)
- The subjects had any history of autoimmune disease or active autoimmune disease.
- Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
- Subjects with severe allergic reactions to other monoclonal antibodies.
- The subjects had a central nervous system metastases of clinical symptoms.
- Central squamous cell lung carcinoma.
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 |
|---|---|---|
| SHR1701PD-L1 / TGF-β RII double antibody | Drug | SHR 1701+radiotherapy |
Primary outcome
Number of participants experiencing adverse event (AE)
Time frame: From the first administration of shr-1701 to 90 days after the last Administration
Number of participants experiencing serious adverse event (SAE)
Time frame: From the first administration of shr-1701 to 90 days after the last Administration
4 secondary outcomes
progression-free survival （PFS）
Time frame: Up to approximately 24 months
Objective Response Rate （ORR）
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- 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.
JinMing Yu, PhD principal investigator
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR1701 in people with Non-Small-Cell Lung Cancer, run by Shandong Cancer Hospital and Institute.
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 11 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 Sep 2020. 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 JinMing Yu, PhD (8613806406293 ext. 8653187984729, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing adverse event (AE) (time frame: From the first administration of shr-1701 to 90 days after the last Administration). 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 23 Sep 2020.