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

Phase 2

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Envafolimab plus Endostar; Drug: Envafolimab plus S-1; Drug: Envafolimab plus Endostar and S-1

• Registration Number: NCT05529355
• Lead Sponsor: Anhui Chest Hospital

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).

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Study Start: 2022-09-18
• Primary Completion: 2023-09-18
• Study Completion: 2023-09-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Envafolimab plus Endostar	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),
Envafolimab plus S-1	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)
Envafolimab plus Endostar and S-1	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)

Primary Outcome Measures

Name	Time	Method
Adverse events	three weeks	safety
objective response rate(ORR)	six weeks	proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors

Secondary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	six weeks	the time from initial treatment to disease progression
overall survival(OS)	six weeks	the time from initial treatment to death from any cause