Phase I/II Study of Nivolumab and Ipilimumab Combined with Nintedanib for Non-Small Cell Lung Cancer

Inclusion Criteria

• Must have advanced or metastatic non-small cell lung cancer (NSCLC) with no curative treatment options.
• Must be 18 years or older.
• Expected to live at least 3-6 months.
• Must be in good overall health with a performance status score of 0 or 1.
• For Phase I: Can be newly diagnosed or have had previous treatments like chemotherapy or immunotherapy.
• For Phase II: Two groups:
  • Arm A: Newly diagnosed and untreated patients, or those whose cancer returned more than 6 months after previous treatment.
  • Arm B: Patients who have had prior immunotherapy.
• Must have at least one measurable tumor.
• Must have normal organ and bone marrow function.
• Must provide a tumor sample for analysis.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.
• Must understand and agree to the study requirements and provide written consent.

Exclusion Criteria

• Cannot use other cancer treatments not specified in the study.
• Cannot participate in another clinical trial with non-FDA-approved drugs within 4 weeks before starting this study.
• Cannot have had recent chemotherapy, immunotherapy, or radiotherapy within 2 weeks before starting this study.
• Cannot have had severe side effects from previous immunotherapy.
• Cannot have had prior treatment with nintedanib.
• Cannot have allergies to the study drugs or their components.
• Cannot have unresolved severe side effects from previous cancer treatments.
• Cannot have active brain metastases or untreated brain conditions.
• Cannot use immunosuppressive medications shortly before starting the study.
• Cannot have active autoimmune diseases within the past 2 years, except for certain conditions like controlled diabetes or thyroid disorders.
• Cannot have tumors invading major blood vessels.
• Cannot have active lung inflammation or pneumonitis.
• Cannot be on certain blood thinners or have recent major surgeries.
• Cannot have significant heart problems or recent heart attacks.
• Cannot have other serious infections or diseases that could interfere with the study.
• Cannot have active hepatitis B or C, or a history of organ transplant.
• Cannot have received live vaccines recently.
• Cannot have gastrointestinal issues affecting drug absorption.
• Cannot have significant weight loss recently.
• Cannot have active tuberculosis.
• Must agree to use effective contraception during and after the study.
• Cannot be pregnant or breastfeeding.
• Cannot have factors that would prevent following the study protocol, such as substance abuse or psychological issues.