Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC

  • STATUS
    Recruiting
  • End date
    Dec 3, 2024
  • participants needed
    46
  • sponsor
    Qilu Hospital of Shandong University
Updated on 25 March 2022

Summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.

Details
Condition Squamous Non-small Cell Lung Cancer
Treatment "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"
Clinical Study IdentifierNCT05243355
SponsorQilu Hospital of Shandong University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed written informed consent;
Aged 18-75 years old;
Histologically or cytologically confirmed, locally advanced (Stage IIIB/C) not amenable to curative surgery or radiotherapy, or metastatic/recurrent (Stage IV) squamous NSCLC according to American Joint Committee on Cancer, 8th Edition;
At least 1 measurable lesion as defined by RECIST v1.1;
ECOG performance status 0-1;
No systematic antitumor treatment for advanced / metastatic diseases has been received in the past;
Life expectancy sup 3 months;
Adequate organ function;
For female subjects of childbearing age, urine or serum pregnancy test shall be conducted 3 days before receiving the first study drug administration, and the result is negative;
The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period

Exclusion Criteria

Histology was non squamous cell NSCLC. Mixed cell types must distinguish the dominant cell morphology (squamous cell carcinoma components > 50% can be included in the group); If there are small cell carcinoma, neuroendocrine carcinoma and sarcoma, they can not be included in the group
EGFR sensitive mutations or ALK rearrangements
Imaging (CT or MRI) showed that the tumor invaded large blood vessels or it was judged that the tumor was very likely to invade important blood vessels and cause fatal bleeding during the follow-up study
Concurrent participation in another clinical trial
Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
Received Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin, etc.) within 2 weeks, or major surgical treatment within 3 weeks before the first administration
There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that need clinical intervention
Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia
Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment
Known allergic reactions to PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin active ingredients and or any excipients
Patients requiring long-term systemic use of corticosteroids
Symptomatic central nervous metastasis
Active infection requiring treatment or systemic anti infective drugs used within one week before the first administration
Not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss)
Known HIV infection
Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greaterthan the upper limit of normal value in the laboratory of the research center)
Active HCV infected
Live vaccine was administered within 30 days before the first administration
Pregnant or lactating women
Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the whole study, or other situations that the researchers believe are not suitable for inclusion
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