A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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NSCLC

Intervention / Treatment
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* Combination Product: Drug intervention


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy | Combination Product: Drug intervention<br>* anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The primary endpoint is the antitumor activities in this study | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival (PFS) | 18 months | 
| OS | Overall survival (OS) | 18 months | 
| DOR | Duration of response (DOR) | 18 months |