Immunotherapy combined with chemotherapy and surgery for early-stage lung cancer

Plain-English translation of NCT07109401 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new immunotherapy drug called tislelizumab, combined with standard chemotherapy and surgery, for people with early-stage small cell lung cancer that doctors believe can be surgically removed. You would receive the medication along with chemotherapy before surgery to help shrink the tumor, then have surgery to remove it, and finally continue treatment for about a year after surgery. The goal is to see whether this combination approach helps people live longer and stay cancer-free.

Currently, surgery alone is only recommended for the smallest, most limited small cell lung cancers. Doctors don't yet know whether adding this new immunotherapy medication before and after surgery can safely extend surgery as a treatment option to people with slightly more advanced disease, and whether it improves survival.

Do you qualify?

You likely qualify if…

you are 18 to 75 years old
you have been diagnosed with small cell lung cancer at stage IIB-IIIB that doctors believe can be surgically removed with curative intent
you have not received prior chemotherapy, radiation therapy, immunotherapy, or surgery for this cancer
you are in good enough health to tolerate both chemotherapy and surgery (ECOG performance status 0-1)
you have adequate heart, lung, liver, and kidney function as confirmed by blood tests and scans

You likely don't qualify if…

you have brain metastases (cancer spread to the brain)
you have a history of interstitial lung disease, pulmonary fibrosis, or radiation pneumonitis
you are currently taking systemic corticosteroids or have taken them within 14 days
you have an active autoimmune or inflammatory disease, or a history of primary immunodeficiency
you are pregnant, breastfeeding, or planning to become pregnant during the study

What participation looks like

Over about 1 year, you would receive the medication by intravenous infusion every 3 weeks for 2–4 cycles, combined with chemotherapy given on specific days. After completing this initial phase, you would undergo surgery to remove the tumor. Following surgery, you would continue receiving the medication plus chemotherapy for a total of four cycles, then receive the medication alone for approximately one year. You'll have regular clinic visits, blood tests, and imaging scans to monitor your health and how well the treatment is working.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(1 site)

China

Fudan University Shanghai Cancer Center, Shanghai