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Non-Small Cell Lung CancerPhase 2/3NCT07662811

SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer

A Phase 2/3 study testing SYHX2011, Carboplatin and Enlonstobart in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Efficacy and Safety of SYHX2011 Combined with Carboplatin and Enlonstobart versus Nab-Paclitaxel Combined with Carboplatin and Tislelizumab as First-Line Treatment for Squamous Non-Small Cell Lung Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
SYHX2011, Carboplatin and Enlonstobart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 31 Dec 2029
Phase
Phase 2/3
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 old
  • Histologically or cytologically confirmed locally advanced or metastatic squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV according to the IASLC 9th Edition TNM Staging System), ineligible for radical surgery and/or radical radiotherapy
  • Confirmed negative for driver genes (including EGFR mutation, ALK fusion, ROS1 fusion, etc.)
  • Tumor cell PD-L1 expression in tumor tissue ≥1% (TPS ≥1%)
  • No prior systemic anti-tumor therapy for Stage IIIB/IIIC and IV NSCLC, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs, Chinese herbal medicines or proprietary Chinese medicines, and other investigational drugs for tumor control
  • ECOG PS score 0~1
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  • At least one measurable lesion according to the RECIST 1.1 criteria
  • Adequate bone marrow and other organ functions:(1)Hematology: No significant signs of hematological disease; absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count (PLT) ≥75×10^9/L, hemoglobin (Hb) ≥90 g/L at screening. For patients with hematological indicators at the critical value who fail to meet the above criteria, the investigator will determine eligibility based on the patient's physical condition. (2)Coagulation function: International Normalized Ratio (INR) ≤1.5 × upper limit of normal (ULN); activated partial thromboplastin time (APTT) ≤1.5 × ULN. (3)Hepatic and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤2.5 × ULN; for patients with hepatic metastasis, both AST and ALT ≤5 × ULN. Total bilirubin (TBiL) ≤1.5 × ULN; for patients with known Gilbert's disease: serum total bilirubin level ≤3 × ULN. Serum creatinine (Cr) ≤1.5 × ULN
  • Expected survival ≥3 months
  • Able to understand the study details; the patient and/or legal guardian voluntarily consents to participate in the study and signs the informed consent form

Who cannot join

  • History of or current with other malignant tumors (excluding non-melanoma skin cancer, in situ breast cancer, in situ cervical cancer, and superficial bladder cancer that have been effectively controlled within the past 5 years)
  • Active leptomeningeal disease or poorly controlled, untreated brain metastases (excluding patients with brain metastases that are well-controlled with local therapy)
  • Interstitial lung disease (ILD), drug-induced interstitial pneumonitis, or non-infectious pneumonitis (including radiation pneumonitis, pulmonary fibrosis, acute lung disease requiring steroid therapy), and patients with severe impairment of pulmonary function
  • Active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). However, participants with the following conditions are eligible for further screening: well-controlled type 1 diabetes mellitus; well-controlled hypothyroidism requiring only hormone replacement therapy; dermatological diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia); or participants with diseases not expected to relapse in the absence of external triggers
  • Peripheral neuropathy of Grade ≥2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
  • Pleural effusion, peritoneal effusion, or pericardial effusion requiring clinical intervention within 2 weeks prior to the first administration of the study drug
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  • History of severe cardiovascular disease within 6 months prior to the first administration of the study drug, including but not limited to:(1)Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); Fridericia-corrected QT interval (QTcF) > 480 ms (Fridericia formula: QTcF=QT/RR^0.33, where RR=60/heart rate);(2)History of myocardial infarction, unstable angina pectoris, angioplasty, or coronary artery bypass graft surgery;(3)Heart failure of New York Heart Association (NYHA) Functional Class Ⅱ or higher; left ventricular ejection fraction (LVEF) < 50% as detected during screening
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBc) positive, with HBV DNA copy number ≥ 1×10^4 copies/mL (or ≥ 2000 IU/mL); Hepatitis C virus antibody (anti-HCV) positive, with HCV RNA level exceeding the lower limit of quantification (LLOQ) of the applied analytical method
  • Severe infection occurring within 4 weeks prior to the first study drug administration (including but not limited to bacteremia requiring hospitalization, severe pneumonia, active pulmonary tuberculosis, etc.); active infection requiring systemic antibiotic therapy within 2 weeks prior to the first study drug administration
  • Lactating or pregnant females; females of childbearing potential with a positive blood pregnancy test within 7 days before study enrollment; all male and female patients of childbearing potential who decline to use highly effective contraceptive methods throughout the study period and for 6 months after the last drug administration
  • Known hypersensitivity or anaphylaxis to any study drug, or a history of other severe hypersensitivity reactions
  • History of immunodeficiency (including positive human immunodeficiency virus (HIV) test results, other acquired or congenital immunodeficiency diseases); a history of allogeneic stem cell or organ transplantation; other conditions that the investigator deems unsuitable for study participation (e.g., psychiatric disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, etc.)

About this study

Official title: SYHX2011 in Combination With Carboplatin and Enlonstobart Versus Nab-Paclitaxel Plus Carboplatin and Tislelizumab as First-Line Therapy for Squamous Non-Small Cell Lung Cancer: A Multicenter, Open-Label, Phase II/III Study

Efficacy and Safety of SYHX2011 Combined with Carboplatin and Enlonstobart versus Nab-Paclitaxel Combined with Carboplatin and Tislelizumab as First-Line Treatment for Squamous Non-Small Cell Lung Cancer

Read the detailed description

This is a multicenter, open-Label, phase II/III study in patients with squamous non-small cell lung cancer. Phase II will adopt a single-arm study design. The first 12 enrolled patients will be designated as the safety run-in cohort. Upon completion of safety observation after the first dose administration, the recommended dose will be selected for the expansion phase based on the safety and efficacy outcomes of the safety run-in phase.If the Phase II study results demonstrate that the combination therapy at the recommended dose is tolerable and has a favorable safety profile in trial participants, with preliminary evidence of anti-tumor activity, the investigators will determine whether to initiate the Phase III study. The current guideline-recommended first-line treatment regimen is planned to be selected as the control arm, and a randomized, controlled, open-label study design will be adopted. Participants will receive the study regimen (experimental arm) or the control regimen in accordance with the randomization results.

Being tested
SYHX2011, Carboplatin, Enlonstobart, Nab-Paclitaxel, Tislelizumab
Keywords
SYHX2011, Enlonstobart, Squamous Non-small Cell Lung Cancer, First-Line Therapy
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.

  • SYHX2011Drug

    Also called Paclitaxel for Injection(Albumin Bound)(II)

    SYHX2011:260 mg/m^2, IV/30 ± 3 minutes(day1)

  • CarboplatinDrug

    Carboplatin: AUC 5 mg/mL/min, IV/30~60 minutes(day1)

  • EnlonstobartDrug

    Also called SG001

    Enlonstobart: 360 mg, IV/60 minutes(day1)

  • Nab-PaclitaxelDrug

    Also called Albumin-bound Paclitaxel

    Nab-Paclitaxel: 260 mg/m^2, IV/30 ± 3 minutes(day1)

  • CarboplatinDrug

    Carboplatin: AUC 5 mg/mL/min, IV/30~60 minutes(day1)

  • TislelizumabDrug

    Tislelizumab: 200 mg, IV/60 minutes(day1)

Study groups in NCT07662811
Study groupRoleWhat they receive
SYHX2011+Carboplatin+EnlonstobartExperimentalSYHX2011+Carboplatin+Enlonstobart, One cycle every 3 weeks for 4~6 cycles. Maintenance therapy consists of SYHX2011 (administered every 6 weeks) and Enlonstobart (administered every 3 weeks), with a maximum duration of 2 years, or until disease progression, intolerable toxicity, or withdrawal of informed consent by the patient, whichever occurs first.
Receives: Drug: SYHX2011; Drug: Carboplatin; Drug: Enlonstobart
Nab-Paclitaxel +Carboplatin+TislelizumabActive comparatorNab-Paclitaxel +Carboplatin+Tislelizumab,One cycle every 3 weeks for 4~6 cycles. Maintenance therapy consists of Nab-Paclitaxel (administered every 6 weeks) and Tislelizumab (administered every 3 weeks), with a maximum duration of 2 years, or until disease progression, intolerable toxicity, or withdrawal of informed consent by the patient, whichever occurs first.
Receives: Drug: Nab-Paclitaxel; Drug: Carboplatin; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) for phase II

    Objective response rate (ORR) is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as RECIST V1.1. This will be considered as the number of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the period of treatment with SYHX2011. Tumor measurements that were assessed locally by the clinician according to RECIST, V1.1, should be recorded and indicate the change in size of tumors as compared with baseline, at the first dose of study treatment.

    Measured: Throughout the study period, an average of 3 years

  2. Progression Free Survival (PFS) for phase III

    Progression free survival (PFS): Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.

    Measured: Throughout the study period, an average of 3 years

Secondary outcomes (6)

  1. Dose-Limiting Toxicity(DLT) only assessed in the safety run-in cohort

    Adverse events (including signs, symptoms, diseases, and clinically significant abnormal laboratory test values) related to the study drug (with causal relationships categorized as definite, probable, or possible) occurring during the DLT observation period.

    Measured: From the first dose finished to 21 days

  2. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    To identify the incidence and the type of AEs, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams.

    Measured: From the first dose finished to 28 days after the last dose

  3. ORR(iRECIST)

    Objective response rate (ORR) is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as iRECIST.

    Measured: Throughout the study period, an average of 3 years

  4. Disease Control Rate(DCR)

    The proportion of patients achieving complete response (CR), partial response (PR), and stable disease (SD) among all patients over the entire study period.

    Measured: Throughout the study period, an average of 3 years

  5. Duration of Response (DoR)

    Duration of response (DoR): is defined as the time from first confirmed response (complete (CR) or partial (PR) response), to the date of the documented progression of the disease (PD) as determined using RECIST V1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.

    Measured: Throughout the study period, an average of 3 years

  6. Overall Survival

    Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the end of the study or was lost to follow-up, survival time was censored at their last contact date or the end of the study date, whichever was first.

    Measured: Throughout the study period, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662811
Sponsor's protocol ID
CSPC-XBZ-LUNG-K01
Status last verified
Jun 2026
First submitted
17 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SYHX2011, Carboplatin and Enlonstobart in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.

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 10 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: opening soon, as of the sponsor's last update on 29 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) for phase II (time frame: Throughout the study period, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662811.

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 29 Jun 2026.

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