NSCLCPhase 2NCT07647094
A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer
A Phase 2 study testing Serplulimab, Nab-Paclitaxel, Carboplatin in people with NSCLC, run by People's Hospital of Quzhou at 1 site in China.
Trial summary
This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Serplulimab, Nab-Paclitaxel, Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent before implementing any trial-related procedures;
- Age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgery and radical concurrent chemoradiotherapy, and subjects who have not previously received systemic treatment;
- Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously irradiated fields can be considered measurable if confirmed to have progressed;
- No prior systemic anti-tumor treatment for advanced/metastatic disease. Subjects who previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be included if disease progression or recurrence occurs at least 6 months after the last chemotherapy drug treatment;
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- Subjects with asymptomatic or symptomatically stable brain metastases after local therapy are allowed to enroll if they meet the following conditions: measurable lesions outside the central nervous system; no central nervous system symptoms or no worsening symptoms within at least 2 weeks; no need for corticosteroid therapy, or corticosteroids discontinued within 7 days prior to first dose, or corticosteroid dose stable and reduced to ≤10 mg/day prednisone (or equivalent) within 7 days prior to first dose;
- Patients may receive palliative radiotherapy, but completion must be at least 7 days before the first dose of the study drug, and radiotherapy-related toxicities must recover to ≤ grade 1 (CTCAE 5.0);
- ECOG performance status 0-1;
- Expected survival >3 months;
- Sufficient organ function: subjects must meet the following laboratory criteria: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L without using granulocyte colony-stimulating factor in the past 14 days; platelet count ≥100 × 10⁹/L without transfusion in the past 14 days; hemoglobin >9 g/dL without transfusion or erythropoietin use in the past 14 days; total bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (for subjects with liver metastases, ALT or AST ≤5 × ULN is allowed); serum creatinine ≤1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can still be included if total T3 (or FT3) and FT4 are within the normal range; myocardial enzyme spectrum within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed to enroll).
- For female subjects of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days before the first study drug administration (Cycle 1, Day 1) and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
- If there is a risk of pregnancy, all subjects (male or female) must use contraception methods with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last study drug administration.
Who cannot join
- Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy within 14 days before treatment; lung lesion radiotherapy with a dose >30Gy within 6 weeks before treatment (subjects must have recovered to grade 1 or below from previous radiotherapy toxicity, without the need for corticosteroid treatment, and no history of radiation pneumonitis); palliative radiotherapy completed within 7 days before the first study drug administration;
- Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ);
- Currently participating in an interventional clinical study treatment or received other study drugs or investigational devices within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);
- Received Chinese patent medicines or immunomodulatory drugs with anti-NSCLC indications (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) for systemic treatment within 2 weeks before the first administration;
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- Experienced active autoimmune disease requiring systemic treatment (e.g., disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years before the first administration. Alternative therapies (e.g., thyroid hormones, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;
- Receiving systemic corticosteroid treatment (excluding nasal, inhaled, or other local corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration; Note: The use of physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) is allowed.
- Presence of clinically uncontrollable pleural effusion/ascites (subjects who do not require drainage or whose effusion does not significantly increase after stopping drainage for 3 days may be enrolled);
- Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to the study drugs Serplulimab, Nab-Paclitaxel, carboplatin, or any of their excipients;
- Has not fully recovered from any toxicities and/or complications caused by prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the detection limit); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: HBV viral load <1000 copies/ml (200 IU/ml) before first dosing; subjects should receive anti-HBV treatment throughout the study chemotherapy to prevent viral reactivation; for subjects who are anti-HBc (), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.
- Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the detection limit);
- Received a live vaccine within 30 days before first dosing (Cycle 1, Day 1); Note: Receiving injectable inactivated vaccines for seasonal influenza within 30 days prior to first dosing is allowed; however, intranasal live attenuated influenza vaccines are not permitted.
- Pregnant or breastfeeding women;
- Presence of any serious or uncontrollable systemic disease, such as: significant and severe uncontrollable abnormalities in resting electrocardiogram in rhythm, conduction, or morphology, such as complete left bundle branch block, second degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥ 2; myocardial infarction within 6 months before enrollment; poorly controlled blood pressure (systolic >140 mmHg, diastolic >90 mmHg); history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before first administration, or current clinically active interstitial lung disease; active pulmonary tuberculosis; presence of active or uncontrolled infection requiring systemic treatment; clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); urinalysis showing proteinuria ≥ , and confirmed 24-hour urine protein quantification >1.0 g; presence of mental disorders making it impossible to comply with treatment;
- History or evidence of disease, treatment or abnormal laboratory test values that may interfere with trial results or prevent the subject from participating in the study, or any other condition which the researcher considers unsuitable for enrollment, or other potential risks that the researcher believes make participation in this study inappropriate.
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
Quzhou people's Hospital
Quzhou, Zhejiang
Xuru Jin, 13857782369, wzjxr@qq.com
About this study
This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.
- Conditions
- NSCLC
- Being tested
- Serplulimab, Nab-Paclitaxel, Carboplatin
- Keywords
- Non-small cell lung cancer
- 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.
Serplulimab, Nab-Paclitaxel, CarboplatinDrug
Standard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. Low Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Other | Low Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day. Receives: Drug: Serplulimab, Nab-Paclitaxel, Carboplatin |
| Routine dose group | Other | Standard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. Receives: Drug: Serplulimab, Nab-Paclitaxel, Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR)
Measured: 36months
Secondary outcomes (6)
The progression free survival (PFS)
Measured: 36months
The disease control rate (DCR)
Measured: 36months
The duration of remission (DOR)
Measured: 36months
The overall survival (OS)
Measured: 36months
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 36months
Incidence of treatment discontinuation due to AE/SAE
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Nov 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Quzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Xuru, People's Hospital of Quzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647094
- Sponsor's protocol ID
- 2025-132
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07647094
- Acronym / sponsor ID
- 2025-132
- Conditions
- NSCLC
- Keywords
- Non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- People's Hospital of QuzhouUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 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 study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Other | Drug: Serplulimab, Nab-Paclitaxel, CarboplatinLow Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day. |
| Routine dose group | Other | Drug: Serplulimab, Nab-Paclitaxel, CarboplatinStandard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign a written informed consent before implementing any trial-related procedures;
- Age ≥18 years and ≤75 years;
- Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgery and radical concurrent chemoradiotherapy, and subjects who have not previously received systemic treatment;
- Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;
- According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously irradiated fields can be considered measurable if confirmed to have progressed;
Key exclusion criteria (19 listed)
- Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
- Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy within 14 days before treatment; lung lesion radiotherapy with a dose >30Gy within 6 weeks before treatment (subjects must have recovered to grade 1 or below from previous radiotherapy toxicity, without the need for corticosteroid treatment, and no history of radiation pneumonitis); palliative radiotherapy completed within 7 days before the first study drug administration;
- Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ);
- Currently participating in an interventional clinical study treatment or received other study drugs or investigational devices within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);
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 |
|---|---|---|
| Serplulimab, Nab-Paclitaxel, CarboplatinStandard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. Low Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day. | Drug | Low dose group, Routine dose group |
Primary outcome
The objective response rate (ORR)
Time frame: 36months
6 secondary outcomes
The progression free survival (PFS)
Time frame: 36months
The disease control rate (DCR)
Time frame: 36months
The duration of remission (DOR)
Time frame: 36months
The overall survival (OS)
Time frame: 36months
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 36months
Incidence of treatment discontinuation due to AE/SAE
Time frame: 36months
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 Sep 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, Nab-Paclitaxel, Carboplatin in people with NSCLC, run by People's Hospital of Quzhou 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 13 inclusion and 19 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 Sep 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 Xuru Jin (13857782369, wzjxr@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective response rate (ORR) (time frame: 36months). 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 Sep 2026.