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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03513666

Acronym

JS001

Enrollment

Registered

2018-05-01

Start date

2018-04-09

Completion date

2022-08-12

Last updated

2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Brief summary

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

Interventions

COMBINATION_PRODUCTDrug intervention

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
PFS	18 months	Progression free survival (PFS)
OS	18 months	Overall survival (OS)
DOR	18 months	Duration of response (DOR)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026