Local Advanced or Metastatic NSCLCPhase 3NCT06380348
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
A Phase 3 study testing JMT101 Injection, Osimertinib tablet and Cisplatin injection in people with Local Advanced or Metastatic NSCLC, run by Shanghai JMT-Bio Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Local Advanced or Metastatic NSCLC
- What is being tested?
- JMT101 Injection, Osimertinib tablet and Cisplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 26 Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and hematologic function
Who cannot join
- 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
- As judged by the investigator, unsuitable for attending the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- JMT101 Injection, Osimertinib tablet, Cisplatin injection, Pemetrexed injection
- Keywords
- Harboring EGFR 20ins mutation, Without prior systemic therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101 InjectionDrug
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
Osimertinib tabletDrug
Osimertinib 160mg once po everyday
Cisplatin injectionDrug
Cisplatin 75mg/m^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
Pemetrexed injectionDrug
Pemetrexed 500mg/m^2, IV infusion, on day-1 at every cycle of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| JMT101 combined with Osimertinib | Experimental | Not described Receives: Drug: JMT101 Injection; Drug: Osimertinib tablet |
| Cisplatin combined with pemetrexed | Active comparator | 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. Receives: Drug: Cisplatin injection; Drug: Pemetrexed injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Secondary outcomes (6)
Overall Survival (OS)
Measured: Up to approximately 35 months after the first participant is randomized
Overall Response Rate (ORR) by IRC per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Duration of Response (DoR) by IRC per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
PFS by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
ORR by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
DoR by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D., Principal investigator, Cancer Prevention and Treatment Center of Sun Yat sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380348
- Sponsor's protocol ID
- JMT101-012
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No