NSCLC, Stage IIIPhase 2NCT05177497
SHR-1701 for Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III NSCLC
A Phase 2 study testing SHR-1701 in people with NSCLC, Stage III, run by Shanghai Chest Hospital.
Trial summary
This is a phase II, open-label, single arm study, aiming to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III non-small-cell lung cancer (NSCLC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage III
- What is being tested?
- SHR-1701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old, both male and female;
- Histologically or pathologically confirmed patients with stage III (according to the International Association for the Study of Lung Cancer and the Joint Committee on American Classification of Cancer TNM Staging System, Version 8), and to be inoperable determined by the investigator;
- The disease did not progress after receiving platinum-based concurrent chemoradiotherapy (at least 2 cycles, chemotherapy regimen: cisplatin/carboplatin combined with pemetrexed is recommended for non-squamous carcinoma, cisplatin/carboplatin combined with paclitaxel is recommended for squamous carcinoma), and the cumulative radiotherapy dose was 50-60Gy;
- ECOG PS score 0-1 points;
- The function of major organs is normal, the following standards are met: a) Routine blood examination(under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction):hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet (PLT) ≥100×10^9/L; white blood cell count (WBC) ≥3.0×10^9/L; b) Biochemical examination: alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin(TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction(LVEF)≥50%;
- The estimated survival time is at least 12 weeks;
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, it should be Surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
- The patient voluntarily participates and signs an informed consent form (or signed by a legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.
Who cannot join
- Prior treatment with any anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies
- Driver gene mutations (EGFR mutation, ALK fusion, etc.)
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection
- Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, but patients who require medical intervention with bronchodilators cannot be included;
- Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration;
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
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- Suffer from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Patients with supraventricular or ventricular arrhythmia requiring clinical intervention
- Suffered from or accompanied with other systemic malignancies in the last 5 years, (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first Administration
- Those who are known to be allergic to any test drug or its excipients;
- Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Other circumstances deemed inappropriate by the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Trial of SHR-1701 Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III Non-small-cell Lung Cancer
This is a phase II, open-label, single arm study, aiming to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III non-small-cell lung cancer (NSCLC)
Read the detailed description
The PACIFIC trial showed that durvalumab consolidation therapy significantly improved PFS and OS versus placebo for patients with unresectable stage III NSCLC after chemoradiotherapy. Pacific regimen has become the standard of care for patients with unresectable stage III NSCLC. SHR-1701, a novel bifunctional fusion protein composed of a mAb against PD-L1 fused with the extracellular domain of TGF-β receptor II, has demonstrated anti-tumor activity in early clinical trials. In this study, the investigators aim to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III NSCLC.
- Conditions
- NSCLC, Stage III
- Being tested
- 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-1701Drug
SHR-1701 administered by iv
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
Measured: From enrollment until confirmed disease progression; up to a maximum of approximately 2 years.
PFS
progression-free survival
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
Secondary outcomes (3)
ORR
objective response rate
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
DCR
disease control rate
Measured: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
OS
overall survival
Measured: From baseline until death due to any cause; up to a maximum of approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IIIStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong Fu, Shanghai Chest Hospital
- Investigators
- Xiao-Long Fu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177497
- Sponsor's protocol ID
- NSCLC-MT-IIT-SHR1701
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SHR-1701 Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05177497
- Acronym / sponsor ID
- NSCLC-MT-IIT-SHR1701
- Conditions
- NSCLC, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Jan 2022 (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 is a phase II, open-label, single arm study, aiming to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III non-small-cell lung cancer (NSCLC)
Detailed description
The PACIFIC trial showed that durvalumab consolidation therapy significantly improved PFS and OS versus placebo for patients with unresectable stage III NSCLC after chemoradiotherapy. Pacific regimen has become the standard of care for patients with unresectable stage III NSCLC. SHR-1701, a novel bifunctional fusion protein composed of a mAb against PD-L1 fused with the extracellular domain of TGF-β receptor II, has demonstrated anti-tumor activity in early clinical trials. In this study, the investigators aim to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: SHR-1701 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old and ≤75 years old, both male and female;
- Histologically or pathologically confirmed patients with stage III (according to the International Association for the Study of Lung Cancer and the Joint Committee on American Classification of Cancer TNM Staging System, Version 8), and to be inoperable determined by the investigator;
- The disease did not progress after receiving platinum-based concurrent chemoradiotherapy (at least 2 cycles, chemotherapy regimen: cisplatin/carboplatin combined with pemetrexed is recommended for non-squamous carcinoma, cisplatin/carboplatin combined with paclitaxel is recommended for squamous carcinoma), and the cumulative radiotherapy dose was 50-60Gy;
- ECOG PS score 0-1 points;
- The function of major organs is normal, the following standards are met: a) Routine blood examination(under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction):hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet (PLT) ≥100×10^9/L; white blood cell count (WBC) ≥3.0×10^9/L; b) Biochemical examination: alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin(TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction(LVEF)≥50%;
Key exclusion criteria (13 listed)
- Prior treatment with any anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies
- Driver gene mutations (EGFR mutation, ALK fusion, etc.)
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection
- Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, but patients who require medical intervention with bronchodilators cannot be included;
- Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration;
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-1701SHR-1701 administered by iv | Drug | treatment arm |
Primary outcome
AE
Time frame: From enrollment until confirmed disease progression; up to a maximum of approximately 2 years.
Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
PFS
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
progression-free survival
3 secondary outcomes
ORR
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
DCR
Time frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
OS
Time frame: From baseline until death due to any cause; up to a maximum of approximately 4 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Yes
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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.
Xiao-Long Fu principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701 in people with NSCLC, Stage III, run by Shanghai Chest Hospital.
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 13 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 4 Jan 2022. 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 Xiao-Long Fu (13651635103, xlfu1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: From enrollment until confirmed disease progression; up to a maximum of approximately 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 4 Jan 2022.