Not Yet RecruitingPhase 2

Local Injection and Systemic Therapy in the Treatment of NSCLC.

84 participantsStarted 2024-10-08

Plain-language summary

This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Volunteer to participate and sign the informed consent form；
✓. ≥ 18 years old; Both men and women are eligible；
✓. Histologically or cytologically confirmed advanced or metastatic locally advanced, advanced (Stage IIIB, IIIC, or IV) NSCLC without mutations in driver gene testing;
✓. Patients with recurrent or metastatic NSCLC who have previously failed first-line standard therapy;
✓. According to Response Evaluation Criteria in Solid Tumors (RECIST1.1), there should be at least one measurable lesion as a target lesion, and the measurable lesion should not have received local therapy such as radiotherapy;
✓. Atelectasis Radiographically assessed atelectasis with at least one lobe;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
✓. Expected survival ≥3 months;

Exclusion criteria

✕. Severe metamorphosis/allergic reaction to humanized antibodies or fusion proteins;
✕. Known hypersensitivity to Endostar or any component of the antibody formulation;
✕. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study, physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent) are permitted;
✕. Exclude subjects with active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers may be enrolled;
✕. Patients with severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease;
✕. Patients who have previously received targeted therapy with vascular endothelial growth inhibitors, such as bevacizumab, Sunitinib, sorafenib, imatinib, Famitinib, Regafenib, Apatinib, androtinib, etc.
✕. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to receiving trial drug) planned within 4 weeks prior to group assignment or during this study. Expansion field radiotherapy (EF-RT) within 4 weeks before grouping or limited field radiotherapy to assess tumor lesions within 2 weeks before grouping;
✕. Active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of assay);

What they're measuring

lung recruitment rate

Timeframe: every 3 weeks during intratumoral treatment in the first two cycles,At the end of Cycle 1and Cycle2 (each cycle is 281days).

Trial details

NCT IDNCT06618391

SponsorHenan Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-03-02

Contact for this trial

Hongbo Wu, M.D.

15981878778 zlyywuhongbo1417@zzu.edu.cn

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials