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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1 year PFS rate
Timeframe: 12 months after the last subject participating in