Study Comparing New Treatments to Standard Care in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Able to give informed consent.
• Aged 18 years or older (19 years or older in Korea).
• Diagnosed with NSCLC (squamous or non-squamous) and have:
  • Disease progression after up to 2 lines of treatment for advanced or metastatic disease, including one line of platinum-based chemotherapy and one line of PD(L)1 monoclonal antibody therapy.
  • For those with BRAF mutations, progression after standard treatment.
  • For those who had prior anti-PD(L)1 therapy, must have had a response or stable disease before progression.
• Have at least one measurable tumor.
• ECOG performance status of 0 or 1.
• Provide a tumor tissue sample.
• Adequate organ function.
• Agree to use effective contraception during and after treatment.
• Life expectancy of at least 12 weeks.

Exclusion Criteria

• Previous treatment with docetaxel or any investigational agents in this study.
• More than 2 prior lines of therapy for NSCLC.
• Other invasive cancers within the last 2 years, except certain treated cancers.
• Carcinomatous meningitis or uncontrolled CNS metastases.
• Major surgery within 28 days before starting the study.
• Autoimmune diseases requiring treatment in the past 2 years.
• Use of systemic steroids or immunosuppressive agents recently.
• Prior organ transplantation.
• Recent live vaccine.
• Unresolved severe side effects from previous cancer treatments.
• Lung diseases like pulmonary fibrosis or pneumonitis.
• Recent uncontrolled fluid buildup or gastrointestinal issues.
• Recent serious heart problems.
• Unstable liver or biliary disease.
• Active infection requiring treatment.
• HIV infection.
• Severe allergies to study drugs.
• Use of certain medications affecting liver enzymes.
• Serious medical or psychiatric conditions.
• Pregnant or breastfeeding women.
• Participation in another study recently.
• Hepatitis B or C infection.
• Recent blood transfusions or growth factor treatments.