Clinical trial · Interventional
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
NCT05529355CI-TRIAL-00060723unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Envafolimab plus Endostar | Drug | — | UNRESOLVED |
| Envafolimab plus Endostar and S-1 | Drug | — | UNRESOLVED |
| Envafolimab plus S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Envafolimab plus Endostar and S-1
- description
- 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)
- interventionNames
- Drug: Envafolimab plus Endostar and S-1
- type
- ACTIVE_COMPARATOR
- label
- Envafolimab plus Endostar
- description
- 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),
- interventionNames
- Drug: Envafolimab plus Endostar
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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:
\-References
Publications (0)
Data not yet available
No reference posted for this study.