Clinical trial · Interventional
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
NCT04448379CI-TRIAL-00049144unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort
- description
- Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
- interventionNames
- Drug: JMT101
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort
- description
- Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
- interventionNames
- Drug: JMT101
Primary outcomes (1)
- measure
- Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZhao S, Zhuang W, Han B, Song Z, Guo W, Luo F, Wu L, Hu Y, Wang H, Dong X, Jiang D, Wang M, Miao L, Wang Q, Zhang J, Fu Z, Huang Y, Xu C, Hu L, Li L, Hu R, Yang Y, Li M, Yang X, Zhang L, Huang Y, Fang W. Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. Nat Commun. 2023 Jun 12;14(1):3468. doi: 10.1038/s41467-023-39139-4. PMID 37308490