NCT04316351

Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance

Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance：a Phase II,Muti-center, Single Arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multi-center, phase II exploratory study that evaluates the efficacy and safety of Toripalimab injection (JS001) combined with Pemetrexed and Anlotinib as a second-line treatment for patients with T790M positive Non-Small Cell Lung Cancer (IIIb / IV ) after Osimertinib resistance.

Conditions

• IIIb/IV NSCLC With T790M Positive Mutations Failed to Osimertinib Therapy

Interventions

Type	Name	Description
DRUG	Toripalimab + Pemetrexed + Anlotinib	Toripalimab 240 mg iv d1 + anlotinib 12mg po d1-d14 + pemetrexed 500mg / m2 d1 Q3W for 4 cycles, followed by Toripalimab 240mg iv d1 + anlotinib 12mg po d1 + pemetrexed 500mg / m2 d1 Q3W for another 31 cycles (up to a total of 35 cycles). If there is no disease progression, patients will receive anlotinib po 12mg d1-d14 + pemetrexed 500mg / m2 d1, Q3W for maintenance therapy until PD per RECIST v1.1 or loss of clinical benefit.

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2020-03-20
• Last updated: 2020-07-23

Locations

1 site across 1 country: China