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

  • STATUS
    Recruiting
  • participants needed
    48
  • sponsor
    Shanghai JMT-Bio Inc.
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Updated on 16 February 2024
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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.

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.

Details
Condition Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Age 18years - 75years
Treatment JMT101
Clinical Study IdentifierNCT04448379
SponsorShanghai JMT-Bio Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 Criteria

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
Clear my responses
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