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

NCT ID: NCT05529355

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-18
• Study Completion Date: 2023-09-18

Brief 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.

Detailed 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Envafolimab plus Endostar and S-1

Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles)

Group Type: EXPERIMENTAL

Envafolimab plus Endostar and S-1

Intervention Type: DRUG

Immunotherapy combined with chemotherapy and anti VEGFR therapy

Envafolimab plus Endostar

Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Recombinant Human Endostartin Injection (210 mg, d1-7 pumps, repeat every 3 weeks, using 4-6 cycles),

Group Type: ACTIVE_COMPARATOR

Envafolimab plus Endostar

Intervention Type: DRUG

Immunotherapy combined with anti VEGFR therapy

Envafolimab plus S-1

Envafolimab (300 mg subcutaneously each time, using 4-6 cycles), Tegafur,Gimeracil and Oteracil Porassium Capsules (40 mg Bid, take 2 weeks stop for 1 week, use 4-6 cycles)

Group Type: ACTIVE_COMPARATOR

Envafolimab plus S-1

Intervention Type: DRUG

Immunotherapy combined with chemotherapy

Interventions

Envafolimab plus Endostar and S-1

Immunotherapy combined with chemotherapy and anti VEGFR therapy

Intervention Type: DRUG

Envafolimab plus Endostar

Immunotherapy combined with anti VEGFR therapy

Intervention Type: DRUG

Envafolimab plus S-1

Immunotherapy combined with chemotherapy

Intervention Type: DRUG

Other Intervention Names

Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules; Envafolimab combined with Recombinant Human Endostatin Injection; Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guan Maojing

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Z-2014-06-2201

Identifier Type: -

Identifier Source: org_study_id