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

NCT05529355 | Unknown Phase 2

• 1 other identifier: Z-2014-06-2201
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• 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

• Adverse events

  safety

  three weeks

Secondary Outcomes (2)

• progression-free survival(PFS)

  six weeks

• overall survival(OS)

  six weeks

Study Arms (3)

Envafolimab plus Endostar and S-1

EXPERIMENTAL

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)

Drug: Envafolimab plus Endostar and S-1

Envafolimab plus Endostar

ACTIVE COMPARATOR

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),

Drug: Envafolimab plus Endostar

Envafolimab plus S-1

ACTIVE COMPARATOR

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)

Drug: Envafolimab plus S-1

Interventions

Envafolimab plus Endostar and S-1 DRUG

Immunotherapy combined with chemotherapy and anti VEGFR therapy

Also known as: Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules

Envafolimab plus Endostar and S-1

Envafolimab plus Endostar DRUG

Immunotherapy combined with anti VEGFR therapy

Also known as: Envafolimab combined with Recombinant Human Endostatin Injection

Envafolimab plus Endostar

Envafolimab plus S-1 DRUG

Immunotherapy combined with chemotherapy

Also known as: Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules

Envafolimab plus S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients are histologically or cytologically confirmed stage IV non-small cell lung cancer. Genetic testing identifies no driver gene mutations.
• Male or female, age \> 18 years, \< 75 years.
• Patients had not received PD-L1 inhibitors in first-line treatment.
• KPS score ≥ 70 points (ECOG score 0-1 points), the expected survival ≥3 months;
• 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:
• Blood routine test:
• Leukocyte WBC≥3.5×109/L; Neutrophil count (ANC) ≥ 1.5×109/L; Platelet (PLT) ≥ 80×109/L;
• 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.

Sponsors & Collaborators

• Anhui Chest Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

envafolimab; endostar protein; S 1 (combination); gimeracil; Endostatins; Tegafur

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 18, 2022
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-09