Phase 3 Study of Toripalimab Alone or with Tifcemalimab for Limited-stage Small Cell Lung Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of limited-stage small cell lung cancer (LS-SCLC) using specific medical criteria.
• Have received a specific type of chemoradiotherapy, including 4 cycles of chemotherapy with carboplatin or cisplatin and etoposide, and a specific dose of radiation.
• Must start the study treatment within 42 days after the last chemotherapy dose.
• Must have had a complete, partial, or stable response to the initial treatment without the cancer getting worse.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate organ function.
• Women of childbearing potential and men with partners of childbearing age must agree to use effective contraception.
• Must agree to participate voluntarily, sign an informed consent form, and comply with all study procedures.

Exclusion Criteria

• Have a mix of small cell lung cancer and non-small cell lung cancer.
• Have received a different sequence of chemoradiotherapy for LS-SCLC.
• Have not fully recovered from side effects of previous cancer treatments.
• Have active or a history of autoimmune diseases.
• Have a history of immune system deficiencies, including HIV, or have had an organ or bone marrow transplant.
• Have a history of lung diseases like interstitial lung disease or pneumonitis, except mild radiation pneumonitis not treated with steroids.
• Have active hepatitis B or C infections.
• Have another type of cancer diagnosed before the study, except for certain low-risk cancers like treated skin cancer or localized prostate cancer.
• Women who are pregnant or breastfeeding.