Non-Small-Cell Lung CancerPhase 2NCT04580498
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
A Phase 2 study testing SHR-1701+Paclitaxel+carboplatin and SHR-1701 in people with Non-Small-Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- SHR-1701+Paclitaxel+carboplatin and SHR-1701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 1 Mar 2025
- 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 70 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 70 years old, both male and female;
- ECOG score: 0-1
- histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
- subjects who can provide fresh or archival tumor tissue;
- Measurable lesions available;
- Major organ function is basically normal;
- Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before randomization;
Who cannot join
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- subjects who have malignant pleural effusion;
- Previous systemic anti-tumor therapy for NSCLC;
- Previous thoracic radiotherapy;
- Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose.
- Systemic immunostimulant therapy before the first dose;
Show all 26Show fewer
- Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
- Subjects with autoimmune diseases;
- Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
- Known or suspected interstitial pneumonia;
- Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
- Severe cardiovascular and cerebrovascular diseases;
- Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
- Arteriovenous thrombotic events within 3 months before the first dose;
- Positive HIV test;
- Active hepatitis B or C;
- Evidence of active tuberculosis infection within 1 year before the first dose;
- Serious infection within 4 years before the first dose;
- History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
- Major surgeries other than diagnosis or biopsy within 28 days prior to first dose;
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
- History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- Allergic to any component of the randomized treatment regimen;
- Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
- Subjects who has a known history of psychotropic drug abuse, alcoholism, or drug abuse
- Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter Phase II Clinical Trial of SHR-1701 With or Without Chemotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III non-small cell lung cancer
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- SHR-1701+Paclitaxel+carboplatin, 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+Paclitaxel+carboplatinDrug
Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5
SHR-1701Drug
Drug: SHR-1701 30mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR-1701+Paclitaxel+carboplatin Receives: Drug: SHR-1701+Paclitaxel+carboplatin |
| Treatment group B | Experimental | SHR-1701 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: From the initiation of the first dose to 3 years
EFS
event free survival
Measured: From the initiation of the first dose to 3 years
Secondary outcomes (4)
OS
overall survival
Measured: From the initiation of the first dose to 3 years
EFS rate
event free survival rate
Measured: From the initiation of the first dose to 3 years
TDDM
time to death or distant metastasis
Measured: From the initiation of the first dose to 3 years
Adverse events(AEs)
Incidence of treatment-related AEs
Measured: From the initiation of the first dose to 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start10 Nov 2020
- Primary completion15 Jul 2023 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580498
- Sponsor's protocol ID
- SHR-1701-II-205
- Status last verified
- May 2023
- First submitted
- 28 Sep 2020
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan Y, Yang X, Zhou Q, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Jia Y, Song L, Shi W, Wu YL. Neoadjuvant retlirafusp alfa (anti-PD-L1/TGF-beta bifunctional fusion protein) with or without chemotherapy in unresectable stage III non-small cell lung cancer: updated results from the phase 2 TRAILBLAZER trial. Signal Transduct Target Ther. 2026 Jun 16;11(1):239. doi: 10.1038/s41392-026-02779-1.
PubMed 42303632
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Clinical Trial of SHR-1701 With or Without Chemotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04580498
- Acronym / sponsor ID
- SHR-1701-II-205
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Oct 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1701+Paclitaxel+carboplatinSHR-1701+Paclitaxel+carboplatin |
| Treatment group B | Experimental | Drug: SHR-1701SHR-1701 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participate in the study and sign the informed consent form;
- 18 to 70 years old, both male and female;
- ECOG score: 0-1
- histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
- subjects who can provide fresh or archival tumor tissue;
Key exclusion criteria (26 listed)
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- subjects who have malignant pleural effusion;
- Previous systemic anti-tumor therapy for NSCLC;
- Previous thoracic radiotherapy;
- Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose.
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+Paclitaxel+carboplatinDrug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5 | Drug | Treatment group A |
| SHR-1701Drug: SHR-1701 30mg/kg | Drug | Treatment group B |
Primary outcome
ORR
Time frame: From the initiation of the first dose to 3 years
Objective response rate
EFS
Time frame: From the initiation of the first dose to 3 years
event free survival
4 secondary outcomes
OS
Time frame: From the initiation of the first dose to 3 years
EFS rate
Time frame: From the initiation of the first dose to 3 years
TDDM
Time frame: From the initiation of the first dose to 3 years
Adverse events(AEs)
Time frame: From the initiation of the first dose to 90 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Derived from this study: PubMed 42303632Pan Y, Yang X, Zhou Q, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Jia Y, Song L, Shi W, Wu YL. Neoadjuvant retlirafusp alfa (anti-PD-L1/TGF-beta bifunctional fusion protein) with or without chemotherapy in unresectable stage III non-small cell lung cancer: updated results from the phase 2 TRAILBLAZER trial. Signal Transduct Target Ther. 2026 Jun 16;11(1):239. doi: 10.1038/s41392-026-02779-1.
Related trials for Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
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.
Yilong Wu, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701+Paclitaxel+carboplatin and SHR-1701 in people with Non-Small-Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 26 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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: From the initiation of the first dose to 3 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?
On the ClinicalTrials.gov record for NCT04580498, which also lists 1 linked publication.
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 19 May 2023.