Resilient: This phase II/III trial is comparing two intravenous drugs (Irinotecan liposome injection and Topotecan injection) in patients with small cell lung cancer who have gotten worse after first line therapyA Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

Inclusion

• At least 18 years of age.
• Able to understand and provide an informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy >12 weeks
• Histopathologically or cytologically confirmed small cell lung cancer
• Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible).
• Radiologically confirmed progression on or after first-line platinum based chemotherapy (carboplatin or cisplatin), or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC). In addition to platinum-based regimen, one line of immunotherapy as monotherapy or in combination, in first or in second line setting is allowed.
• Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to Grade 1 or better, with the exception of alopecia, peripheral neuropathy, or ototoxicity).
• Adequate bone marrow reserves
• Adequate hepatic function
• Adequate renal function
• Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment

• Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.

  1. Patients with asymptomatic CNS metastases prior to enrollment
  2. Prior radiation for CNS metastatic disease is completed ≥4 weeks prior to enrollment
  3. CNS metastases that are stable or have decreased according to the post radiation follow-up scan that is conducted at least 4 weeks after completion of radiation treatment for CNS lesion.
  4. Patients have discontinued corticosteroids or are on stable low-dose steroids (prednisone or equivalent 10 mg daily or less) for at least 1 week after completion of radiation for CNS lesion prior to enrollment.