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

Squamous Non-small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Advanced (Stage IIIB-IV) Squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243355
• Other study ID #: SMA-NSCLC-005
• Status: Recruiting
• Phase: Phase 2
• Start date: December 3, 2021
• Est. completion date: December 3, 2024

Study information

• Verified date: December 2021
• Source: Qilu Hospital of Shandong University
• Contact: Lian Liu, Doctor
• Phone: 18560082903
• Email: tounao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 3, 2024
• Est. primary completion date: December 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-small Cell Lung Cancer

Intervention

Drug:
• "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"
Envafolimab: 300 mg,D1,Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin:210mg,CIV 72h,d1-3,Q3W,4-6 cycles in total.

Locations

Country	Name	City	State
China	Qilu hospital of Shandong univertisy	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year PFS rate	12-month progression free survival in ITT population	12 months after the last subject participating in
Secondary	ORR	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects	24 months after the last subject participating in
Secondary	DOR	DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.	24 months after the last subject participating in
Secondary	PFS	Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first	24 months after the last subject participating in
Secondary	OS	OS is defined as the time from the starting date of study drug to the date of death due to any cause.	24 months after the last subject participating in