Clinical trial · Observational
Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
NCT04116918CI-TRIAL-00041016unknownClinicalTrials.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)
This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anlotinib | — | UNRESOLVED | — |
| EGFR T790M-negative | — | UNRESOLVED | — |
| JS001 | — | UNRESOLVED | — |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
- description
- Time from treatment beginning until disease progression
- measure
- Objective Response Rate
- timeFrame
- Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
- description
- Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients \>=18 years of age * Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation * EGFR-TKI resistent * EGFR T790M negative * Expected survival ≥ 3 month; * ECOG / PS score: 0-2; * the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min Exclusion Criteria: * EGFR-T790M positive * with druggable gene alteration; * Patient can not comply with research program requirements or follow-up;
References
Publications (0)
Data not yet available
No reference posted for this study.