Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

Last updated: December 23, 2020
Sponsor: Shanghai JMT-Bio Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04448379
JMT101-CSP-001
  • Ages 18-75
  • All Genders

Study 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 metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previously treated with EGFR antibody;
  • Symptomatic brain metastasis;
  • Interstitial pneumopathy;
  • Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or theirexcipients;
  • 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.

Study Design

Total Participants: 48
Study Start date:
June 29, 2020
Estimated Completion Date:
June 30, 2022

Study 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 insertion mutations.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Chinese Pla General Hospital

    Beijing,
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha,
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing,
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing,
    China

    Active - Recruiting

  • Shanghai Chest Hospital, Shanghai Jiaotong University

    Shanghai,
    China

    Active - Recruiting

  • Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)

    Taiyuan,
    China

    Active - Recruiting

  • Shanxi Province Cancer Hospital

    Taiyuan,
    China

    Active - Recruiting

  • Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology

    Wuhan,
    China

    Active - Recruiting

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