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

ConditionLocal Advanced or Metastatic NSCLC

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai JMT-Bio Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

JMT101 Injection
Drug
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
Osimertinib tablet
Drug
Osimertinib 160mg once po everyday
Cisplatin injection
Drug
Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
Pemetrexed injection
Drug
Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.

Treatment groups

398 Participants

are divided into 2 treatment groups

Group A: JMT101 combined with OsimertinibExperimental treatment 2 interventions

Group B: Cisplatin combined with pemetrexedActive comparator 2 interventions