NSCLC (Non-small Cell Lung Cancer)Phase 2NCT07596121
Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
A Phase 2 study testing Serplulimab in people with NSCLC (Non-small Cell Lung Cancer), run by Tang-Du Hospital at 1 site in China.
Trial summary
This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Serplulimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2026to 31 May 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance.
- 2.Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender.
- 3.Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV NSCLC according to the AJCC 8th edition staging system.
- 4.PD-L1 Expression: Tumor tissue confirmed as PD-L1 TPS≥50% by a central laboratory or a validated local laboratory, using SP263 or 22C3 assays (a formal test report must be provided).
- 5.Driver Gene Status: Known absence of actionable driver mutations, including but not limited to EGFR sensitive mutations, ALK fusions, and ROS1 fusions.
- 6.Measurable Disease: At least one measurable target lesion per RECIST v1.1 criteria (lesions must not have received prior radiotherapy).
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- 7.Prior Treatment History: No prior systemic therapy for advanced or metastatic disease. For patients who received adjuvant or neoadjuvant chemotherapy, inclusion is permitted if disease recurrence occurred ≥6 months after the completion of the last dose.
- 8.Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.
- 9.Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor therapy within 14 days prior to the first dose):
- Absolute Neutrophil Count (ANC)≥1.5 x 10^9//L
- Platelet Count (PLT)≥100 x 10^9//L
- Hemoglobin (Hb)≥90 g/L
- Serum Creatinine (Cr) ≤ 1.5 x Limit of Normal (ULN) or Creatinine Clearance ≥ 50mL/min
- Total Bilirubin (TBIL) ≤ 1.5 x ULN
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN(≤ 5 x ULN for patients with liver metastases)
Who cannot join
- 1. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipients.
- 2. Prior Immunotherapy: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors (ICIs).
- 3. Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.
- 4. Lung Disease/Pneumonitis: Active interstitial lung disease (ILD) or pneumonitis, or a history of (non-infectious) pneumonitis requiring steroid treatment.
- 5. Infections: Active infection requiring systemic therapy. 6. CNS Metastases: Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. However, patients with treated (via surgery or radiotherapy) and stable brain metastases are eligible, provided they are radiographically stable for at least 4 weeks prior to the first dose, have no evidence of new or enlarged brain lesions, and have discontinued glucocorticoids for at least 14 days.
- 7. Pregnancy and Breastfeeding: Pregnant or breastfeeding women. 8. Investigator Discretion: Any other condition that, in the investigator's opinion, may interfere with the evaluation of the study drug, jeopardize subject safety, or confound the interpretation of study results.
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
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, 710000
Lei Pan, Dr, 13991161903, panlei@fmmu.edu.cn
About this study
Official title: Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
This prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design.
The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027.
Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Serplulimab
- Keywords
- NSCLC, Serplulimab, PD-L1 TPS≥50%, Monotherapy
- 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.
SerplulimabDrug
The treatment follows a 21-day (3-week) cycle. Serplulimab is administered intravenously at a fixed dose of 300 mg on Day 1 of each cycle (Q3W). Prior to each administration, subjects shall undergo comprehensive clinical assessments-including vital signs, anthropometric measurements, physical examinations, laboratory monitoring, and ECOG performance status (PS)-to confirm safety and tolerability for continued treatment.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab Monotherapy | Experimental | Not described Receives: Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Secondary outcomes (3)
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause)
Measured: The maximum time from receiving treatment to dying for any reason is 4 years.
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Disease Control Rate
Disease Control Rate (DCR) is defined as the percentage of participants who achieved a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Disease Control Rate (DCR) is analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start13 May 2026
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Tang-Du 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596121
- Sponsor's protocol ID
- HLX10IIT321
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%
- ClinicalTrials.gov ID
- NCT07596121
- Acronym / sponsor ID
- HLX10IIT321
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- NSCLC, Serplulimab, PD-L1 TPS≥50%, Monotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 May 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 prospective clinical study aims to evaluate and observe the efficacy and safety of Serplulimab Monotherapy in Elderly Patients with NSCLC and PD-L1 TPS ≥ 50% using a multicenter, single-arm, phase II design.
The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in May 2026, and recruitment is expected to conclude around May 2026, with the trial anticipated to end by May 2027.
Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab Monotherapy | Experimental | Drug: Serplulimab |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 1.Voluntary participation and informed consent: Subjects must voluntarily join the study, sign the written informed consent form (ICF), and demonstrate good compliance.
- 2.Age and Gender: Aged ≥65 years at the time of signing the ICF, regardless of gender.
- 3.Diagnosis and Staging: Histologically or cytologically confirmed Stage IIIB (ineligible for definitive chemoradiotherapy), Stage IIIC, or Stage IV NSCLC according to the AJCC 8th edition staging system.
- 4.PD-L1 Expression: Tumor tissue confirmed as PD-L1 TPS≥50% by a central laboratory or a validated local laboratory, using SP263 or 22C3 assays (a formal test report must be provided).
- 5.Driver Gene Status: Known absence of actionable driver mutations, including but not limited to EGFR sensitive mutations, ALK fusions, and ROS1 fusions.
Key exclusion criteria (6 listed)
- 1. Hypersensitivity: Known hypersensitivity to serplulimab or any of its excipients.
- 2. Prior Immunotherapy: Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitors (ICIs).
- 3. Autoimmune Disease: Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.
- 4. Lung Disease/Pneumonitis: Active interstitial lung disease (ILD) or pneumonitis, or a history of (non-infectious) pneumonitis requiring steroid treatment.
- 5. Infections: Active infection requiring systemic therapy. 6. CNS Metastases: Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. However, patients with treated (via surgery or radiotherapy) and stable brain metastases are eligible, provided they are radiographically stable for at least 4 weeks prior to the first dose, have no evidence of new or enlarged brain lesions, and have discontinued glucocorticoids for at least 14 days.
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 |
|---|---|---|
| SerplulimabThe treatment follows a 21-day (3-week) cycle. Serplulimab is administered intravenously at a fixed dose of 300 mg on Day 1 of each cycle (Q3W). Prior to each administration, subjects shall undergo comprehensive clinical assessments-including vital signs, anthropometric measurements, physical examinations, laboratory monitoring, and ECOG performance status (PS)-to confirm safety and tolerability for continued treatment. | Drug | Serplulimab Monotherapy |
Primary outcome
Progression-free survival
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
3 secondary outcomes
Overall Survival
Time frame: The maximum time from receiving treatment to dying for any reason is 4 years.
Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Disease Control Rate
Time frame: Disease Control Rate (DCR) is analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 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 19 May 2026.
- 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 Phase 2 study testing Serplulimab in people with NSCLC (Non-small Cell Lung Cancer), run by Tang-Du Hospital 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 15 inclusion and 6 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 19 May 2026. 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?
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 Lei Pan, Dr (13991161903, panlei@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 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 19 May 2026.