Clinical trial NCT06380348: 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
Official title: A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Local Advanced or Metastatic NSCLC
Keywords: Harboring EGFR 20ins mutation
Without prior systemic therapy
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-23
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 35 months after the first participant is randomized
measure: Overall Response Rate (ORR) by IRC per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
measure: Duration of Response (DoR) by IRC per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
measure: PFS by investigator per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
measure: ORR by investigator per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
measure: DoR by investigator per RECIST 1.1
timeFrame: Up to approximately 35 months after the first participant is randomized
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Prevention and Treatment Center of Sun Yat sen University
name: Li Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: