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

COMPLETEDPHASE2

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

NCT03513666•Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

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;

Locations (5)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Shanghai Pulmonary Hospita

Shanghai, Shanghai Municipality, China

Tangdu Hospital

Xi’an, Shanxi, China

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Zhengjiang Cancer Hospital

Hangzhou, Zhengjiang, China

Key Dates

Start Date

April 9, 2018

Primary Completion Date

August 12, 2022

Completion Date

August 12, 2022

Last Updated

August 23, 2023

Enrollment

ACTUAL participants

Conditions

NSCLC

Interventions

Drug intervention

COMBINATION_PRODUCT

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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