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

Phase 3

Not yet recruiting

• Conditions: Local Advanced or Metastatic NSCLC
• Interventions: Drug: Cisplatin injection; Drug: JMT101 Injection; Drug: Osimertinib tablet; Drug: Pemetrexed injection

• Registration Number: NCT06380348
• Lead Sponsor: Shanghai JMT-Bio Inc.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Study Start: 2024-04-26
• Primary Completion: 2027-03-26
• Study Completion: 2028-03-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 398

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin combined with pemetrexed	Cisplatin injection	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.
JMT101 combined with Osimertinib	JMT101 Injection	-
JMT101 combined with Osimertinib	Osimertinib tablet	-
Cisplatin combined with pemetrexed	Pemetrexed injection	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PFS by investigator per RECIST 1.1	Up to approximately 35 months after the first participant is randomized
DoR by investigator per RECIST 1.1	Up to approximately 35 months after the first participant is randomized
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
ORR by investigator 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