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

NCT03513666 | Completed Phase 2

• 1 other identifier: JS001-PII-LC-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The primary endpoint is the antitumor activities in this study

  12 weeks

Secondary Outcomes (3)

• PFS

  18 months

• OS

  18 months

• DOR

  18 months

Study Arms (1)

treatment arm

EXPERIMENTAL

Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy

Combination Product: Drug intervention

Interventions

Drug intervention COMBINATION_PRODUCT

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

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (5)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Shanghai Pulmonary Hospita

Shanghai, Shanghai Municipality, China

Location

Tangdu Hospital

Xi’an, Shanxi, China

Location

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Zhengjiang Cancer Hospital

Hangzhou, Zhengjiang, 310022, China

Location

Related Publications (1)

• Li LC, Chen XW, Fang L, Jian CL, Yu YX, Liao XY, Sun JG. YAP1 as a Novel Negative Biomarker of Immune Checkpoint Inhibitors for EGFR-Mutant Non-Small-Cell Lung Cancer. Can Respir J. 2023 Jun 21;2023:4689004. doi: 10.1155/2023/4689004. eCollection 2023.

  PMID: 37388902 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: April 9, 2018
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

CN (5)