Clinical trial · Interventional
A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment:a Multi-center, Single Arm Phase II Study
NCT03513666CI-TRIAL-00069016JS001completedPhase 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)
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment:a multi-center, single arm phase II study
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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug intervention | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy
- interventionNames
- Combination Product: Drug intervention
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 12 weeks
- description
- The primary endpoint is the antitumor activities in this study
Secondary outcomes (3)
- measure
- PFS
- timeFrame
- 18 months
- description
- Progression free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: * Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: * Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; * No exon 20 T790M mutation after failure of EGFR-TKI therapy; * At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: * Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component \>10%; * Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; * Previous systemic chemotherapy for advanced NSCLC; * EGFR-TKI therapy within two weeks prior to enrollment;
References
Publications (1)
- DERIVEDLi LC, Chen XW, Fang L, Jian CL, Yu YX, Liao XY, Sun JG. YAP1 as a Novel Negative Biomarker of Immune Checkpoint Inhibitors for EGFR-Mutant Non-Small-Cell Lung Cancer. Can Respir J. 2023 Jun 21;2023:4689004. doi: 10.1155/2023/4689004. eCollection 2023. PMID 37388902