A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations

ConditionsLocally Advanced or Metastatic Non-squamous NSCLC Harboring EGFR Sensitive Mutations NSCLC Previously Untreated Systematically NSCLC

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorShanghai JMT-Bio Inc.

About this trial

This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able to understand and voluntarily sign the written informed consent form (ICF);

Age ≥ 18 years old, male or female;

Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced or metastatic (stage IIIB, IIIC, or IV) according to the International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria.

Participants who have no prior systemic anti-tumor therapy (including anti-EGFR targeted therapy, chemotherapy, biotherapy, immunotherapy, or any investigational drug) for locally advanced or metastatic NSCLC and are not amenable to radical surgery or radiotherapy. For participants with recurrent disease after prior surgical treatment who have undergone prior adjuvant and neoadjuvant therapy, it is necessary to confirm that there is no recurrence or metastasis of tumor within 6 months after surgery, and the randomization is > 6 months from the end of adjuvant/neoadjuvant therapy;

Disqualifiers

Participants with concomitant mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, and HER2, for which targeted drugs are commercially available for clinical treatment, who will not benefit from this clinical study as judged by the investigator; or participants with other mutations who will not benefit from this clinical study as judged by the investigator;

Have received Chinese patent medicine preparations for the treatment of lung cancer as an indication within 2 weeks prior to randomization;

Have received local radiotherapy within 2 weeks prior to randomization; have received more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks prior to randomization;

Presence of pericardial effusion (small amount of pericardial effusion stable for ≥ 2 weeks prior to randomization is allowed);

Trial design

Design model

Parallel

Treatments tested in this trial

JMT101
Drug
JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.
Osimertinib
Drug
EGFR TKI

Treatment groups

516 Participants

are divided into 2 treatment groups

Group A: JMT101Experimental treatment 1 intervention

Group B: OsimertinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

PFS assessed by the independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time frame