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

NSCLC Clinical Trial

— JS001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513666
• Other study ID #: JS001-PII-LC-001
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2018
• Est. completion date: August 12, 2022

Study information

• Verified date: August 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• NSCLC

Intervention

Combination Product:
• Drug intervention
anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	Zhengjiang Cancer Hospital	Hangzhou	Zhengjiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Pulmonary Hospita	Shanghai	Shanghai
China	Tangdu Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	The primary endpoint is the antitumor activities in this study	12 weeks
Secondary	PFS	Progression free survival (PFS)	18 months
Secondary	OS	Overall survival (OS)	18 months
Secondary	DOR	Duration of response (DOR)	18 months