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

NCT04316351 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316351 on ClinicalTrials.gov