Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Osimertinib

Pemetrexed

Cisplatin

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Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

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 Injection, 6 mg/kg intravenously, over 90 mins every 14 days

JMT101 Injection

Osimertinib tablet

Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.

Cisplatin injection

Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.

Pemetrexed injection

Clinical Trials Information Group officer

Li Zhang, M.D.

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).

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 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

Shanghai JMT-Bio Inc.

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Pemetrexed 20mg every 24 hours for 72 hours every 2 weeks until efficacy evaluated remission or stable ; change to every 3 weeks.

Pemetrexed 30mg D1 every week until efficacy evaluated remission or stable ; change to every 3 weeks.

Group 1（20mg）:induction stage is 20 mg per 24 hours for 72 hours, every 2 weeks; consolidation stage is 20mg per 24 hours for 72 hours, every 3 weeks.

Group 2（30mg）:induction stage is 30 mg D1，every week.Consolidation stage is 30 mg D1,every 3 weeks.

bin Li, doctor

xiangping Li, pharmacist

bin li, doctor

xiangping li, pharmacist

This is a open-label, multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy. In detail: At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer; or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer; or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.

Participants were randomizedly assigned in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 2 weeks,or in cohort 2 will be given pemetrexed 30mg once a week.

It was designed for two stages on treatment course. Induction therapy: Efficacy evaluation every 2 cycles, and confirm the efficacy at the next cycle. If at the next cycle, the efficacy result changed (such as SD or PR after initial PD; or PD after initial SD or PR; the second time of efficacy assess was required）. If the CSF cytology at the time of the efficacy evaluation was negative, one more cycle was required to confirm the CSF cytology.

Consolidation: If the efficacy is remission(including complete remission, obvious remission, or partial remission) or stable disease for initial timepoint and the timepoint of the confirmed evaluation; then the patient will be advanced to the stage of consolidation treatment. Participants in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 3 weeks. Participants in cohort 2 will be given pemetrexed 30mg every 3 weeks. Until the toxicity is intolerable, or disease progression.

Cross over： Compared the first 4 enrolled cases in each group; the comprehensive evaluation(including efficacy, cytology negative, toxicity) in better group(50% higher efficacy or 50% less toxicity) will be the following cohort, to which the other one will crossover.

Cerebrospinal fluid(CSF) supernatants are retained for the detection of cytokines and Pemetrexed concentration.

Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir

A Open-label, Random, Multi-central Prospective Cohort of Observation Study on the Efficacy and Safety of Intraventricule Pemetrexed Disodium Via Ommaya Reservoir

we will share the some dates to the website:http://www.medresman.org.cn/login.aspx or publication of results of clinical trials in the form of papers

ORR is the ratio of the patients who achieve the complete remission(CR), obvious remission(OR), or partial remission(PR) to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90.

obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline.

partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline.

DCR is the ratio of the patients who achieve the CR, OR, PR,or SD to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90.

obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline.

partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline.

stable disease (one of the following items ):the improved items on the RNAO examinations less than 50%; the change of Glasgow Coma Scale within 1 score compared to baseline; the change of KPS within 10 scores.

time to the progression of disease. Progression of disease(one of the following items): The deterioration of at least 25% items on the RNAO examinations; the drop of Glasgow Coma Scale more than 1 score compared to baseline; the drop of KPS score more than 10 scores.

negative results using glass slide centrifugation accompanied with staining

number of participants with treatment-related adverse events or severe adverse effect as assessed by CTCAE 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT06380348	Local Advanced ...	JMT101 Injectio... Osimertinib tab... Cisplatin injec... Pemetrexed inje...	18 Years - 75 Years	Shanghai JMT-Bio Inc.
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir	NCT06399926	Leptomeningeal ... Lung Cancer	Pemetrexed inje... Pemetrexed	18 Years -	Xiangya Hospital of Central South University
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	NCT06380348	Local Advanced ...	JMT101 Injectio... Osimertinib tab... Cisplatin injec... Pemetrexed inje...	18 Years - 75 Years	Shanghai JMT-Bio Inc.
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir	NCT06399926	Leptomeningeal ... Lung Cancer	Pemetrexed inje... Pemetrexed	18 Years -	Xiangya Hospital of Central South University

Spots Global Cancer Trial Database for pemetrexed injection