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

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Combination Product: Drug intervention

• Registration Number: NCT03513666
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-01
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Drug intervention	Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	12 weeks	The primary endpoint is the antitumor activities in this study

Secondary Outcome Measures

Name	Time	Method
DOR	18 months	Duration of response (DOR)
PFS	18 months	Progression free survival (PFS)
OS	18 months	Overall survival (OS)

Trial Locations

Locations (5)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Tangdu Hospital; 🇨🇳 Xi'an, Shanxi, China

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Shanghai Pulmonary Hospita; 🇨🇳 Shanghai, Shanghai, China

Zhengjiang Cancer Hospital; 🇨🇳 Hangzhou, Zhengjiang, China