Immunotherapy plus chemo and radiation shows promise for bulky lung cancer
NCT ID NCT05888402
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the immunotherapy drug toripalimab to standard chemotherapy and radiation can help people with large, locally advanced non-small cell lung cancer. About 50 participants will receive two cycles of toripalimab plus chemo, followed by chemoradiation and then up to a year of toripalimab. The main goal is to see how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (an immunotherapy drug) plus chemotherapy and radiation therapy
- What this could lead to
- If successful, this combination could improve how long people with bulky lung cancer live without their disease getting worse.
- What could go wrong
- This is a small, early-phase trial (50 people) with no control group, so results may not be definitive. Immunotherapy can cause serious immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years; ECOG score 0-1. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes. 4. No other previous anti-tumor history, at least 3 months of expected survival. 5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: 1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. 2. Patients with other active malignancies within 5 years or at the same time. 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). 4. History of allogeneic organ transplantation. 5. History of active primary immunodeficiency. 6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. 7. Women of child-bearing potential who are pregnant or breastfeeding. 8. Allergic to research drug ingredients. 9. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose 10. The investigator judged other situations not suitable for inclusion in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China