Status:
UNKNOWN
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Shanghai JMT-Bio Inc.
Collaborating Sponsors:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metasta...
Detailed Description
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 in...
Eligibility Criteria
Inclusion
- Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
- No previous treatment or first-line treatment failed NSCLC;
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
Exclusion
- Previously treated with EGFR antibody;
- Symptomatic brain metastasis;
- Interstitial pneumopathy;
- Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
- Receiving an investigational product in another clinical study within 4 weeks;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04448379
Start Date
June 29 2020
End Date
June 30 2022
Last Update
December 28 2020
Active Locations (13)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
3
Chinese Pla General Hospital
Beijing, China
4
Hunan Cancer Hospital
Changsha, China