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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2022-08-12

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

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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy

Group Type EXPERIMENTAL

Drug intervention

Intervention Type COMBINATION_PRODUCT

anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

Interventions

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Drug intervention

anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

Intervention Type COMBINATION_PRODUCT

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No