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

NCT ID: NCT06380348

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-26
• Study Completion Date: 2028-03-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JMT101 combined with Osimertinib

Group Type: EXPERIMENTAL

JMT101 Injection

Intervention Type: DRUG

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

Osimertinib tablet

Intervention Type: DRUG

Osimertinib 160mg once po everyday

Cisplatin combined with pemetrexed

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.

Group Type: ACTIVE_COMPARATOR

Cisplatin injection

Intervention Type: DRUG

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

Pemetrexed injection

Intervention Type: DRUG

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

Interventions

JMT101 Injection

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

Intervention Type: DRUG

Osimertinib tablet

Osimertinib 160mg once po everyday

Intervention Type: DRUG

Cisplatin injection

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

Intervention Type: DRUG

Pemetrexed injection

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age between 18-75 years old.

2. 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.

3. At least 1 measurable lesion per RECIST Version 1.1

4. Life expectancy ≥ 12 weeks

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

6. Adequate organ and hematologic function

Exclusion Criteria

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.

2. Central nervous system metastasis with associated symptom and signs.

3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.

4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy

5. As judged by the investigator, unsuitable for attending the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Prevention and Treatment Center of Sun Yat sen University

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@mail.ecspc.com

86-0311-69085587

Other Identifiers

JMT101-012

Identifier Type: -

Identifier Source: org_study_id