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:
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.
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).
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.
Jian-Guo Zhou, MD, PhD
Lead sponsor
Second Affiliated Hospital of Zunyi Medical University
Sponsor institution