Effect and Safety of Envafolimab Combined With Endostar/S-1 in Second-line of Advanced Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

An Exploratory Non-randomized Controlled Trial for Effect and Safety of Envafolimab Combined With Recombinant Human Endostartin Injection/S-1 in Second-line Treatment of Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05529355
• Other study ID #: Z-2014-06-2201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 18, 2022
• Est. completion date: September 18, 2023

Study information

• Verified date: September 2022
• Source: Anhui Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial was a randomized, open-label, multicenter Phase II study of patients with advanced or metastatic NSCLC who don't harbor driver genes. The aim is to explore the efficacy and safety of Envafolimab Combined With Endostar/S-1 in second-line treatment of advanced non-small cell lung cancer.

Description:

Patients with advanced (stage IV. NSCLC), after signing informed consent, are screened to meet the admission requirements. All the candidates are not randomly placed in 3 treatment groups (which treatment regimen the patient chooses is determined by the clinical supervisor on a patient-by-case basis).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.

2. Male or female, age > 18 years, < 75 years.

3. Patients had not received PD-L1 inhibitors in first-line treatment.

4. KPS score = 70 points (ECOG score 0-1 points), the expected survival =3 months;

5. No dysfunction of major organs. EcG, liver function, renal function, and blood count tests before treatment are normal or basically normal, but must meet the following experimental results:

1. Blood routine test:

Leukocyte WBC=3.5×109/L; Neutrophil count (ANC) = 1.5×109/L; Platelet (PLT) = 80×109/L;

2. Blood biochemical test:

Total bilirubin (TBIL) = 1.5 times the upper limit of normal values; Alanine aminotransferase (ALT/SGPT) and alanine transaminases (AST/SGOT) = 2.5 times the normal high value (ULN), or = 5 times the upper limit of normal value in patients with liver metastases; Serum creatinine (Cr) = 1.5 times the upper limit of normal values; c. Cardiac function test: 50% of the left ventricular ejection function of the heart >; 6) The subject has good compliance, and can cooperates with follow-up.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Envafolimab plus Endostar and S-1
Immunotherapy combined with chemotherapy and anti VEGFR therapy
• Envafolimab plus Endostar
Immunotherapy combined with anti VEGFR therapy
• Envafolimab plus S-1
Immunotherapy combined with chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate(ORR)	proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors	six weeks
Primary	Adverse events	safety	three weeks
Secondary	progression-free survival(PFS)	the time from initial treatment to disease progression	six weeks
Secondary	overall survival(OS)	the time from initial treatment to death from any cause	six weeks