Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatme… (NCT05243355) | Clinical Trial Compass
UnknownPhase 2
Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC
China46 participantsStarted 2021-12-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 t…
What they're measuring
1
1 year PFS rate
Timeframe: 12 months after the last subject participating in