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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Envafolimab plus Endostar and S-1; Drug: Envafolimab plus Endostar; Drug: Envafolimab plus S-1

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).

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Drug: Envafolimab plus Endostar and S-1; Immunotherapy combined with chemotherapy and anti VEGFR therapy; Other Names: Envafolimab combined with Recombinant Human Endostatin Injection/Tegafur,Gimeracil and Oteracil Porassium Capsules
ACTIVE_COMPARATOR: 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),	Drug: Envafolimab plus Endostar; Immunotherapy combined with anti VEGFR therapy; Other Names: Envafolimab combined with Recombinant Human Endostatin Injection
ACTIVE_COMPARATOR: 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)	Drug: Envafolimab plus S-1; Immunotherapy combined with chemotherapy; Other Names: Envafolimab combined with Tegafur,Gimeracil and Oteracil Porassium Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival(PFS)	the time from initial treatment to disease progression	six weeks
overall survival(OS)	the time from initial treatment to death from any cause	six weeks

Collaborators and Investigators

• Sponsor: Anhui Chest Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 18, 2022
• Primary Completion (ANTICIPATED): September 18, 2023
• Study Completion (ANTICIPATED): September 18, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein; Endostatins; Tegafur
• Other Study ID Numbers: Z-2014-06-2201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No