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
JMT101 Injection
+ Osimertinib tablet
+ Cisplatin injection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: April 26, 2024
Actual date on which the first participant was enrolled.This clinical trial is focused on finding an effective treatment for patients with a specific type of advanced lung cancer, known as non-small cell lung cancer, which has a mutation called EGFR Exon 20 insertion. The study compares two treatment combinations: JMT101 with Osimertinib, and Cisplatin with Pemetrexed. This trial is important because patients with this mutation often have limited treatment options, and the study aims to discover if the new combination can provide better outcomes in terms of slowing down the progression of the disease. Participants in this trial will be randomly assigned to receive one of the two treatment combinations. One group will receive JMT101 and Osimertinib, while the other group will receive Cisplatin and Pemetrexed. The trial will measure how long participants live without their cancer getting worse, which is known as progression-free survival, as evaluated by an independent review center. The study will also consider factors like whether participants have brain metastasis and their overall health status to ensure fair comparisons. This study involves around 398 participants and aims to provide insights into which treatment might be more effective and safer for those affected.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.398 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives