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The primary outcome measure is the proportion of participants who are alive and free from disease progression at one year after initiating treatment. Progression is defined according to RECIST v1.1 criteria as a 20% increase in the sum of diameters of target lesions, the appearance of new lesions, or the worsening of non-target disease
The rate of participants achieving a clinical complete response assessed by RECIST v1.1 criteria. A clinical complete response is defined as the disappearance of all target lesions and normalization of tumor marker levels.
Overall survival is defined as the time from the start of treatment to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of the last known follow-up.
Duration of response is measured from the time measurement criteria are first met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
The incidence and severity of adverse events categorized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Qualitasured using validated instruments such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). The quality of life score is calculated based on the rules set by EORTC (range 0-100). A lower score indicates better quality of life on the symptom scales, while a higher score indicates better quality of life scores on the overall health and functional scales.
The study will implement a pre-specified safety threshold where if the incidence of Grade 3 pneumonia, as categorized by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), exceeds 15% of participants, the trial may be modified or halted to assess and mitigate risks to patient safety.