CClinicalTrials.gg
RecruitingNCT07247227Updated Nov 25, 2025

Real-world First-line Sugemalimab-Chemotherapy in Advanced NSCLC

An interventional study of Sugemalimab and Chemotherapy in NSCLC, sponsored by Peking Union Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Peking Union Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Oct 2023, registered Nov 2025).
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NSCLC

Keywords

  • sugemalimab
  • NSCLC
03

In context

Lead sponsor

Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years.
  2. Patients voluntarily join the study and sign an informed consent form for the study.
  3. 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).
  4. 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.).
  5. Patients with stage III NSCLC who are not suitable for surgery at a multidisciplinary discussion or investigators' assessment.
  6. Patients with at least one measurable target lesion by CT scan/MRI (RECISTv1.1).
  7. Patients with active brain metastases and liver metastases could be enrolled (Concurrent radiotherapy, intervention, dehydration, and other local treatment are permitted).
  8. 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.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. All patients carry activating mutations of EGFR, ALK, ROS1, and RET. (No more mutation test needed).
  2. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer).
  3. Histopathologically or cytopathologically confirmed non-NSCLC.
  4. Any prior treatment of antibody/drug that targets T-cell coregulatory proteins (not limited to CTLA-4 inhibitors or other agents targeting T cells).
  5. 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).
  6. 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.
  7. Pregnant or lactating women.
  8. 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).
  9. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before 1st line therapy.
  10. Participation in other anti-tumor drug clinical trials within 4 weeks before first-line therapy.
  11. 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.
  12. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    stage IV NSCLC.

    Sugemalimab 1200mg plus 4-6 cycles of platinum-based chemotherapy

    Drug: Sugemalimab and Chemotherapy

  • Experimental
    stage III NSCLC.

    sugemalimab+platinum-based chemotherapy in stage III NSCLC.

    Drug: Sugemalimab and Chemotherapy

Interventions

  • DrugSugemalimab and Chemotherapy

    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.

06

What researchers measure

Primary outcomes

  1. rw-PFS

    rw-PFS, defined as the time from the start of 1st line treatment to tumor progression or death, which occurs first

    Time frame: From enrollment to the end of treatment at 1 year

Secondary outcomes

  1. TTF

    time from the start of the first dose of first-line therapy to treatment failure due to any cause.

    Time frame: From enrollment to the end of treatment at 1 year

  2. OS

    OS defined as the time from the start of treatment to death from any cause.

    Time frame: From enrollment to the end of treatment at 1 year

  3. 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.

    Time frame: From enrollment to the end of treatment at 1 year

  4. DCR

    the proportion of patients with disease control (CR,PR or SD), as assessed by RECIST version 1.1

    Time frame: From enrollment to the end of treatment at 1 year

  5. 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

    Time frame: From enrollment to the end of treatment at 1 year

  6. 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

    Time frame: From enrollment to the end of treatment at 1 year

  7. 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.

    Time frame: Up to 24 months from treatment initiation (with OS rates assessed at 12, 18, and 24 months)

07

Study locations

1 of 1 sites recruiting
  • cancer hospital, Chinese Academy of medical sciences and Peking union medical college
    Beijing, Beijing Municipality 100021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07247227
Lead sponsor
Peking Union Medical College
Responsible party
Junling Li (professor, Peking Union Medical College) — Principal investigator
First posted
Nov 25, 2025
Start date
Oct 10, 2023
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 25, 2025

Study contacts

Li Junling doctor
Contact
lijunling@cicams.ac.cn
+86 13801178891

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion