Phase 2 Study of DS-1062a in Advanced Non-Small Cell Lung Cancer with Biomarker Analysis for Therapy Response

The primary objective of this Phase 2, open-label study is to evaluate the efficacy of **DS-1062a**, an anti-TROP-2-antibody-drug conjugate (ADC), in adult patients with advanced and/or unresectable **Non-Small Cell Lung Cancer (NSCLC)** who have progressed on at least one line and not more than three lines of prior therapy for metastatic/unresectable NSCLC. This study aims to assess the therapeutic potential of DS-1062a in a population with limited treatment options, thereby addressing a significant unmet clinical need in the management of NSCLC. The study also includes biomarker analysis to characterize the response to therapy, which may provide insights into the mechanisms of action and potential predictive markers of response.

The clinical trial involves **adult patients** diagnosed with metastatic and/or unresectable **Non-Small Cell Lung Cancer (NSCLC)** who have experienced disease progression after receiving at least one and no more than three lines of prior therapy for metastatic/unresectable NSCLC. The study population includes both male and female participants, with an age range encompassing adults and older adults. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and specific inclusion or exclusion criteria are not detailed in the available data.

The clinical trial is a **Phase 2, open-label study** designed to evaluate the efficacy and safety of DS-1062a, an anti-TROP-2-antibody-drug conjugate, in adult patients with advanced and/or unresectable **Non-Small Cell Lung Cancer (NSCLC)**. The study aims to include patients who have progressed on at least one line and not more than three lines of prior therapy for metastatic or unresectable NSCLC. The trial is expected to commence recruitment on May 12, 2021, and is estimated to conclude by December 12, 2025.

The trial design involves a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will undergo regular follow-up visits to monitor their response to the treatment and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

Participants are expected to be involved in the study for its entire duration unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed appropriate by the study investigators. The trial's methodology ensures that data collection and analysis are conducted in a systematic and unbiased manner, adhering to the highest standards of clinical research.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is in Phase 4, with an estimated recruitment start date of May 12, 2021, and an estimated end date of December 12, 2025. Efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints for efficacy assessment are not provided. The trial will follow a systematic approach to measure, collect, and analyze data, adhering to the standards expected in Phase 4 trials. The methods and schedule for these assessments are not detailed in the available data. The trial will ensure that all efficacy assessments are conducted using scientifically validated tools and methodologies appropriate for a Phase 4 clinical trial. The focus will be on gathering robust and reliable data to evaluate the efficacy of the intervention under investigation.