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Squamous Non-Small Cell Lung Cancer SqNSCLCPhase 2NCT06747169

Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study

A Phase 2 study testing Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin in people with Squamous Non-Small Cell Lung Cancer SqNSCLC, run by Jian-Guo Zhou, MD, PhD.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

The goal of this single-arm, multi-center phase II clinical study is to evaluate the efficacy and safety of recombinant human endostatin (rh-Endostatin) combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors in patients with locally advanced, advanced, or recurrent metastatic squamous non-small… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
17 Dec 2024to 17 Dec 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must voluntarily participate in the study and provide written informed consent.
  • Age between 18 and 70 years, applicable to both sexes.
  • Histologically or cytologically confirmed advanced or metastatic (Stage IIIB, IIIC, or IV) squamous NSCLC without driver gene mutations.
  • At least one measurable target lesion per RECIST 1.1 criteria, untreated with local therapies (e.g., radiotherapy).
  • ECOG performance status score of 0-1.
  • Expected survival ≥ 3 months.
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  • Treatment-naïve patients (no prior systemic anti-tumor therapy, including radiotherapy, chemotherapy, targeted, or immunotherapy), or patients with recurrence ≥ 6 months after adjuvant chemotherapy.
  • Adequate organ function within 7 days prior to treatment:
  • 1）Hematology (without recent blood transfusion): Hemoglobin (HB) ≥ 90 g/L Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelets (PLT) ≥ 80 × 10⁹/L 2）Biochemistry: Total bilirubin (TBIL) ≤ 1.5 × ULN ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min Serum albumin ≥ 35 g/L 3) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Tissue samples required for biomarker analysis (e.g., PD-L1): newly obtained samples are preferred. Archived samples (collected within 2 years prior to enrollment) are acceptable, with 3-5 μm paraffin sections (5-8 slides).

Who cannot join

  • History of severe hypersensitivity or allergic reactions to humanized antibodies or fusion proteins.
  • Known hypersensitivity to recombinant human endostatin or any component of antibody preparations.
  • Diagnosed with immunodeficiency or receiving systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment (physiologic doses of corticosteroids, such as ≤10 mg/day prednisone or equivalent, are allowed).
  • Active, known, or suspected autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism). However, patients with Type 1 diabetes, hypothyroidism requiring only hormone replacement, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or autoimmune conditions not expected to recur in the absence of external triggers may be included.
  • Pre-existing severe cardiac conditions, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, or severe valvular disease.
  • Prior treatment with anti-angiogenic drugs (e.g., bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regorafenib, apatinib, anlotinib).
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  • Planned systemic anti-tumor therapy (e.g., cytotoxic therapy) within 4 weeks before randomization or during the study.
  • Active hepatitis B (HBV DNA ≥2000 IU/ml or 10⁴ copies/ml) or active hepatitis C (positive anti-HCV and detectable HCV RNA).
  • Active tuberculosis (TB) infection based on chest X-ray, sputum examination, or clinical assessment. Patients with a history of active TB within the past year, even if treated, are excluded. Patients with a history of TB more than one year ago may participate only if prior anti-TB treatment was deemed appropriate.
  • Symptomatic brain metastases or brain metastases with symptom control <2 months.
  • Major surgical procedures, incisional biopsy, or significant traumatic injuries within 28 days prior to randomization.
  • Tumors invading major blood vessels or with a high risk of vascular invasion and fatal hemorrhage, as determined by investigators.
  • Evidence or history of bleeding diathesis, regardless of severity. Patients with unresolved wounds, ulcers, or fractures, or those experiencing bleeding events ≥CTCAE Grade 3 within 4 weeks prior to randomization are excluded.
  • Venous or arterial thrombotic events (e.g., stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the past 6 months.
  • Any comorbidity that, in the investigator's judgment, pose a significant risk to patient safety or interfere with study completion.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jianguo zhou contact

+8618311543939

Jianguo.zhou@zmu.edu.cn

About this study

Official title: Efficacy and Safety of PD-1 Inhibitor Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study

The goal of this single-arm, multi-center phase II clinical study is to evaluate the efficacy and safety of recombinant human endostatin (rh-Endostatin) combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors in patients with locally advanced, advanced, or recurrent metastatic squamous non-small cell lung cancer (NSCLC).

The main questions it aims to answer are:

Read more

What is the progression-free survival (PFS) and objective response rate (ORR) of this combination therapy? What is the safety profile, including adverse event (AE) and serious adverse event (SAE) rates? Researchers will compare the treatment effects over time by evaluating tumor responses using RECIST 1.1 criteria and assessing quality of life using the EORTC QLQ-C30 (v3.0) and QLQ-CX24 scales.

Participants will:

Receive 4-6 cycles of rh-Endostatin combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors.

Continue maintenance treatment with rh-Endostatin and PD-1 inhibitors until disease progression or intolerable toxicity.

Being tested
Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatinDrug

    All patients were treated with a combination therapy consisting of sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin. The study is designed to assess the efficacy and safety of this treatment regimen in the specified population.

Study groups in NCT06747169
Study groupRoleWhat they receive
Locally Advanced/Advanced or Recurrent Metastatic Sq-NSCLCExperimentalThis cohort includes patients with locally advanced, advanced, or recurrent metastatic squamous non-small cell lung cancer (Sq-NSCLC).
Receives: Drug: Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS refers to the length of time from the start of treatment until the tumor progresses or the patient dies, typically assessed through imaging or clinical evaluation. This endpoint reflects the effectiveness of the treatment in delaying disease progression. PFS is particularly useful in evaluating the clinical efficacy of new drugs or therapies. An extension of PFS is usually considered a sign of effective treatment.

    Measured: From the initiation of treatment (Day 1) until the first occurrence of disease progression, death, or the end of the study, whichever came first，up to approximately 5 years.

Secondary outcomes (3)

  1. Overall survival（OS）

    OS is defined as the time from the initiation of treatment to the date of death from any cause. If a patient is alive at the end of the study or lost to follow-up, OS will be censored at the last known date of follow-up.

    Measured: From the initiation of treatment (Day 1) until death or the end of the study, whichever occurs first, up to approximately 7 years

  2. Adverse Events (AE) and Serious Adverse Events (SAE)

    Safety and tolerability will be assessed by recording the incidence of adverse events (AEs) and serious adverse events (SAEs). The proportion of patients experiencing AEs/SAEs and the proportion of events leading to treatment discontinuation will be recorded and analyzed.

    Measured: From the initiation of treatment (Day 1) until 90 days after the last dose of treatment.

  3. Objective response rate(ORR)

    ORR refers to the proportion of patients who achieve either a complete response (CR) or partial response (PR) during treatment. This endpoint reflects the effectiveness of the treatment in controlling the tumor. It is typically assessed through imaging techniques (e.g., CT, MRI) and scored based on RECIST (Response Evaluation Criteria in Solid Tumors) or similar criteria. ORR is a common efficacy endpoint in cancer clinical trials.

    Measured: Assessed after every two cycles of treatment (each cycle is 21 days) through study completion, up to 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 posted24 Dec 2024
  2. Study start17 Dec 2024 (estimated)
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion17 Dec 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747169
Sponsor's protocol ID
KYLL-2024-061
Status last verified
Dec 2024
First submitted
14 Dec 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin in people with Squamous Non-Small Cell Lung Cancer SqNSCLC, run by Jian-Guo Zhou, MD, PhD.

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 15 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 27 Dec 2024. 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 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 Jianguo zhou (+8618311543939, Jianguo.zhou@zmu.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 (PFS) (time frame: From the initiation of treatment (Day 1) until the first occurrence of disease progression, death, or the end of the study, whichever came first，up to approximately 5 years.). 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 NCT06747169.

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 27 Dec 2024.

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