NSCLCNCT07247227
Real-world First-line Sugemalimab-Chemotherapy in Advanced NSCLC
A study testing Sugemalimab and Chemotherapy in people with NSCLC, run by Peking Union Medical College at 1 site in China.
Trial summary
This single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Sugemalimab and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to May 2027
- Phase
- Interventional
- 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.
- Patients voluntarily join the study and sign an informed consent form for the study.
- ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision).
- Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.).
- Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment.
- Patients with at least one measurable target lesion by CT scan/MRI (RECISTv1.1).
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- Patients with active brain metastases and liver metastases could be enrolled (Concurrent radiotherapy, intervention, dehydration, and other local treatment are permitted).
- Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms of grade 2, can be included after symptomatic treatment until recovery to grade 0-1.
- Fertile men and women of childbearing age must agree to take effective contraceptive measures from signing the main informed consent until 180 days after the last dose of the study drug. Women of childbearing potential include premenopausal women and women within 2 years of menopause. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.
Who cannot join
- All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).
- Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- Histopathologically or cytopathologically confirmed non-NSCLC.
- Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).
- Any tumor history within the past 5 years prior to the start of treatment in this study (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors with surgical resection alone and at least 5 consecutive years of disease-free survival).
- Patients with active, unstable systemic disease, active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrhythmia, severe liver, kidney, or metabolic diseases, HIV infection.
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- Pregnant or lactating women.
- Systemic anti-tumor therapy planned within 4 weeks before first-line treatment or during medication after enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (with the exception of thymosin, lentinan, and other immunomodulator therapy).
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before 1st line therapy.
- Participation in other anti-tumor drug clinical trials within 4 weeks before first-line therapy.
- Active, known, or suspected autoimmune diseases. Vitiligo and Type I diabetes mellitus with no systemic treatment are allowed. Residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy is allowed.
- With known mental illness, alcoholism, drug abuse, or other factors which may cause termination of this study, affect the safety of subjects, or collection of data and samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
cancer hospital， Chinese Academy of medical sciences and Peking union medical college
Beijing, Beijing Municipality, 100021
Li Junling doctor, +86 13801178891, lijunling@cicams.ac.cn
About this study
Official title: Sugemalimab Plus Platinum-based Chemotherapy as First-line Therapy for Patients With Locally Advanced and Metastatic Non-small Cell Lung Cancer (NSCLC) in a Real-world Setting: a Single-arm, Multi-center Study
This single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting.
- Conditions
- NSCLC
- Being tested
- Sugemalimab and Chemotherapy
- Keywords
- sugemalimab, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugemalimab and ChemotherapyDrug
Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy as first-line therapy, followed by Sugemalimab 1200mg to 35 cycles, or until disease progression, or ICF withdrawn by participants, or death or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| stage IV NSCLC. | Experimental | Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy Receives: Drug: Sugemalimab and Chemotherapy |
| stage III NSCLC. | Experimental | sugemalimab+platinum-based chemotherapy in stage III NSCLC. Receives: Drug: Sugemalimab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rw-PFS
rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (7)
TTF
time from the start of the first dose of first-line therapy to treatment failure due to any cause.
Measured: From enrollment to the end of treatment at 1 year
OS
OS defined as the time from the start of treatment to death from any cause.
Measured: From enrollment to the end of treatment at 1 year
Objective response rate (ORR)
the proportion of patients with a complete response (CR) or a partial response (PR), as assessed by RECIST version 1.1 Subjects with measurable disease and CR or PR determined at least 4 weeks after initial CR or PR would be considered responders.
Measured: From enrollment to the end of treatment at 1 year
DCR
the proportion of patients with disease control (CR,PR or SD), as assessed by RECIST version 1.1
Measured: From enrollment to the end of treatment at 1 year
DOR
For subjects who demonstrated CR or PR, duration of response (DOR) is defined as the time from first documented evidence of CR or PR until disease progression or death
Measured: From enrollment to the end of treatment at 1 year
Safety, number of participants with treatment-related adverse events (AEs)
Including treatment-emergent adverse reactions (AEs), drug-related AEs, serious adverse reactions (SAEs), and drug-related SAEs
Measured: From enrollment to the end of treatment at 1 year
12-month, 18-month, and 24-month overall survival (OS) rates
The 12-, 18-, and 24-month overall survival (OS) rates are defined as the proportions of patients who are alive at 12, 18, and 24 months after treatment initiation, respectively.
Measured: Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start10 Oct 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junling Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247227
- Sponsor's protocol ID
- NCC3980
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugemalimab Plus Platinum-based Chemotherapy as First-line Therapy for Patients With Locally Advanced and Metastatic Non-small Cell Lung Cancer (NSCLC) in a Real-world Setting: a Single-arm, Multi-center Study
- ClinicalTrials.gov ID
- NCT07247227
- Acronym / sponsor ID
- NCC3980
- Conditions
- NSCLC
- Keywords
- sugemalimab, NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Nov 2025 (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 single-arm, multi-center study is to evaluate Sugemalimab plus platinum-based chemotherapy as first-line therapy for patients with locally advanced and metastatic NSCLC in a real-world setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stage IV NSCLC. | Experimental | Drug: Sugemalimab and ChemotherapySugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy |
| stage III NSCLC. | Experimental | Drug: Sugemalimab and Chemotherapysugemalimab+platinum-based chemotherapy in stage III NSCLC. |
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.
- Patients voluntarily join the study and sign an informed consent form for the study.
- ECOG PS score 0-3 (patients with PS score 2-3 would be enrolled if due to the tumor disease and anticipated to be improved at investigators' decision).
- Histologically documented, stage III, IV non-Small Cell Lung Cancer (according to version 8th of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated systematically(excluding local therapy for local lesions or symptomatic relief, palliative radiotherapy, intervention, intrathecal injection, nerve block, etc.).
- Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment.
Key exclusion criteria (12 listed)
- All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).
- Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
- Histopathologically or cytopathologically confirmed non-NSCLC.
- Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).
- Any tumor history within the past 5 years prior to the start of treatment in this study (except cured cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors with surgical resection alone and at least 5 consecutive years of disease-free survival).
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 |
|---|---|---|
| Sugemalimab and ChemotherapySugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy as first-line therapy, followed by Sugemalimab 1200mg to 35 cycles, or until disease progression, or ICF withdrawn by participants, or death or unacceptable toxicity. | Drug | stage III NSCLC., stage IV NSCLC. |
Primary outcome
rw-PFS
Time frame: From enrollment to the end of treatment at 1 year
rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first
7 secondary outcomes
TTF
Time frame: From enrollment to the end of treatment at 1 year
OS
Time frame: From enrollment to the end of treatment at 1 year
Objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 1 year
DCR
Time frame: From enrollment to the end of treatment at 1 year
DOR
Time frame: From enrollment to the end of treatment at 1 year
Safety, number of participants with treatment-related adverse events (AEs)
Time frame: From enrollment to the end of treatment at 1 year
12-month, 18-month, and 24-month overall survival (OS) rates
Time frame: Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months)
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugemalimab and Chemotherapy in people with NSCLC, run by Peking Union Medical College 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 9 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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.
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 Li Junling doctor (+86 13801178891, lijunling@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rw-PFS (time frame: From enrollment to the end of treatment at 1 year). 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 25 Nov 2025.