NSCLC Stage IIIPhase 2NCT07619911
SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer
A Phase 2 study testing SHR-1701 combined with platinum-doublet chemotherapy induction therapy, SHR-1701 consolidation therapy and Platinum-doublet chemotherapy in people with NSCLC Stage III and SHR-1701, run by Fudan University.
Trial summary
This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage III, SHR-1701, Chemoradiotherapy
- What is being tested?
- SHR-1701 combined with platinum-doublet chemotherapy induction therapy, SHR-1701 consolidation therapy and Platinum-doublet chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, male or female.
- Baseline ECOG performance status 0-1.
- Histologically or cytologically confirmed unresectable stage III NSCLC
- Life expectancy ≥3 months
- No prior anti-tumor therapy
- No known EGFR/ALK/ROS1 sensitive mutations
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- At least one measurable lesion according to RECIST v1.1
- Adequate organ function
- Signed informed consent
Who cannot join
- Mixed small-cell and non-small-cell lung cancer histology
- Known EGFR/ALK/ROS1 mutations
- Prior systemic anti-cancer therapy within 4 weeks
- Active autoimmune disease requiring systemic treatment
- Active infection including uncontrolled HBV, HCV or HIV infection
- Significant cardiovascular disease
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- Uncontrolled hypertension
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial
This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.
- Conditions
- NSCLC Stage III, SHR-1701, Chemoradiotherapy
- Being tested
- SHR-1701 combined with platinum-doublet chemotherapy induction therapy, SHR-1701 consolidation therapy, Platinum-doublet chemotherapy, radiotherapy
- Keywords
- NSCLC, SHR-1701, chemoradiotherapy
- 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 combined with platinum-doublet chemotherapy induction therapyDrug
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 consolidation therapyDrug
SHR-1701 consolidation therapy
Platinum-doublet chemotherapyDrug
Platinum-doublet chemotherapy
radiotherapyRadiation
Thoracic concurrent radiotherapy, total dose 60 Gy ±10%
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 induction Group | Experimental | SHR-1701 combined with platinum-doublet chemotherapy induction therapy followed by concurrent chemoradiotherapy and SHR-1701 consolidation therapy. Receives: Drug: SHR-1701 combined with platinum-doublet chemotherapy induction therapy; Drug: SHR-1701 consolidation therapy; Drug: Platinum-doublet chemotherapy; Radiation: radiotherapy |
| Control Group | Active comparator | Standard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy Receives: Drug: SHR-1701 consolidation therapy; Drug: Platinum-doublet chemotherapy; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: 4 years
Secondary outcomes (6)
Objective Response Rate (ORR)
Measured: 4 years
Disease Control Rate (DCR)
Measured: 4 years
Overall Survival (OS)
Measured: 4 years
Treatment-Related Adverse Events (TRAE)
Measured: 4 years
Serious Adverse Events (SAE)
Measured: 4 years
Treatment-Emergent Adverse Events (TEAE)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2030 (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 Fudan UniversityThe 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619911
- Sponsor's protocol ID
- MA-NSCLC-II-065
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07619911
- Acronym / sponsor ID
- MA-NSCLC-II-065
- Conditions
- NSCLC Stage III, SHR-1701, Chemoradiotherapy
- Keywords
- NSCLC, SHR-1701, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Jun 2026 (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 randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 induction Group | Experimental | Drug: SHR-1701 combined with platinum-doublet chemotherapy induction therapy, Drug: SHR-1701 consolidation therapy, Drug: Platinum-doublet chemotherapy, Radiation: radiotherapySHR-1701 combined with platinum-doublet chemotherapy induction therapy followed by concurrent chemoradiotherapy and SHR-1701 consolidation therapy. |
| Control Group | Active comparator | Drug: SHR-1701 consolidation therapy, Drug: Platinum-doublet chemotherapy, Radiation: radiotherapyStandard concurrent chemoradiotherapy followed by SHR-1701 consolidation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years, male or female.
- Baseline ECOG performance status 0-1.
- Histologically or cytologically confirmed unresectable stage III NSCLC
- Life expectancy ≥3 months
- No prior anti-tumor therapy
Key exclusion criteria (9 listed)
- Mixed small-cell and non-small-cell lung cancer histology
- Known EGFR/ALK/ROS1 mutations
- Prior systemic anti-cancer therapy within 4 weeks
- Active autoimmune disease requiring systemic treatment
- Active infection including uncontrolled HBV, HCV or HIV infection
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 combined with platinum-doublet chemotherapy induction therapySHR-1701 combined with platinum-doublet chemotherapy induction therapy | Drug | SHR-1701 induction Group |
| SHR-1701 consolidation therapySHR-1701 consolidation therapy | Drug | Control Group, SHR-1701 induction Group |
| Platinum-doublet chemotherapyPlatinum-doublet chemotherapy | Drug | Control Group, SHR-1701 induction Group |
| radiotherapyThoracic concurrent radiotherapy, total dose 60 Gy ±10% | Radiation | Control Group, SHR-1701 induction Group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 4 years
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Treatment-Related Adverse Events (TRAE)
Time frame: 4 years
Serious Adverse Events (SAE)
Time frame: 4 years
Treatment-Emergent Adverse Events (TEAE)
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701 combined with platinum-doublet chemotherapy induction therapy, SHR-1701 consolidation therapy and Platinum-doublet chemotherapy in people with NSCLC Stage III and SHR-1701, run by Fudan University.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengfei Zhu (+8618017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 4 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 2 Jun 2026.