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

S

Shanghai JMT-Bio

Status and phase

Not yet enrolling
Phase 3

Conditions

Local Advanced or Metastatic NSCLC

Treatments

Drug: Cisplatin injection
Drug: Pemetrexed injection
Drug: JMT101 Injection
Drug: Osimertinib tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT06380348
JMT101-012

Details and patient eligibility

About

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).

Enrollment

398 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

398 participants in 2 patient groups

JMT101 combined with Osimertinib
Experimental group
Treatment:
Drug: Osimertinib tablet
Drug: JMT101 Injection
Cisplatin combined with pemetrexed
Active Comparator group
Description:
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.
Treatment:
Drug: Pemetrexed injection
Drug: Cisplatin injection

Trial contacts and locations

0

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Central trial contact

Clinical Trials Information Group officer

Data sourced from clinicaltrials.gov

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