JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

NCT06380348 | Not Yet Recruiting Phase 3

• 1 other identifier: JMT101-012
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy. Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).

Conditions

Local Advanced or Metastatic NSCLC

Keywords

Harboring EGFR 20ins mutation; Without prior systemic therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1

  Up to approximately 35 months after the first participant is randomized

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to approximately 35 months after the first participant is randomized

• Overall Response Rate (ORR) by IRC per RECIST 1.1

  Up to approximately 35 months after the first participant is randomized

• Duration of Response (DoR) by IRC per RECIST 1.1

  Up to approximately 35 months after the first participant is randomized

• PFS by investigator per RECIST 1.1

  Up to approximately 35 months after the first participant is randomized

• ORR by investigator per RECIST 1.1

  Up to approximately 35 months after the first participant is randomized

Study Arms (2)

JMT101 combined with Osimertinib

EXPERIMENTAL

Drug: JMT101 Injection; Drug: Osimertinib tablet

Cisplatin combined with pemetrexed

ACTIVE COMPARATOR

Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m\^2 + cisplatin 75mg/m\^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Drug: Cisplatin injection; Drug: Pemetrexed injection

Interventions

JMT101 Injection DRUG

JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days

JMT101 combined with Osimertinib

Osimertinib tablet DRUG

Osimertinib 160mg once po everyday

JMT101 combined with Osimertinib

Cisplatin injection DRUG

Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.

Cisplatin combined with pemetrexed

Pemetrexed injection DRUG

Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.

Cisplatin combined with pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years old.
• Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.
• At least 1 measurable lesion per RECIST Version 1.1
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate organ and hematologic function

You may not qualify if:

• Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
• Central nervous system metastasis with associated symptom and signs.
• Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
• History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
• As judged by the investigator, unsuitable for attending the study.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Li Zhang, M.D.

  Cancer Prevention and Treatment Center of Sun Yat sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 23, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): March 26, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share