Can a new immunotherapy combo outsmart advanced lung cancer?
NCT ID NCT05758116
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase II trial is testing whether the immunotherapy drug tislelizumab can help control locally advanced non-small cell lung cancer when given after radiation therapy or sequential chemoradiation. The study enrolls people with stage III lung cancer who cannot tolerate the standard concurrent chemoradiation and have not progressed after initial treatment. Participants receive tislelizumab every three weeks for about a year, and researchers will track how long they live without the cancer progressing, overall survival, and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab, an immunotherapy drug given intravenously every three weeks for about a year
- What this could lead to
- If it works, this could offer a new treatment option for people with locally advanced lung cancer who cannot tolerate standard concurrent chemoradiation, potentially helping to delay cancer progression.
- What could go wrong
- This is a small, early-phase trial with only 5 participants, so results may not apply broadly. Immunotherapy can cause immune-related side effects, and the treatment may not improve outcomes for everyone.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
5 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
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Jun 2026
- Lead sponsor
-
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 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery; 2. Intolerable of concurrent chemoradiation; 3. No progression after radiotherapy or sequential chemoradiation; 4. Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy; 5. ECOG PS0-2; 6. PD-L1≥1%; 7. Age≥18 years, and life expectancy\>3 months; 8. Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose); 9. Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule. Exclusion Criteria: 1. Patients with EGFR-sensitive mutations and ALK rearrangements; 2. Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway); 3. History of allergy to components of Tislelizumab; 4. Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ); 5. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids; 6. Progression after radiotherapy or sequential chemoradiation; 7. Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia); 8. Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation; 9. Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed); 10. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start; 11. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 12. History of active autoimmune disease requiring systemic therapy; 13. Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications; 14. History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval \>480 ms during screening period; 15. Abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; ALT/AST \> 2.5 times of the upper limit of normal value in patients without liver metastases and ALT/AST \> 5 times of the upper limit of normal value in patients with liver metastases\], abnormal renal function (serum creatinine \> 1.5 times of the upper limit of normal value); 16. History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ; 17. History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia; 18. Unsuitable for participation in this study assessed by investigators; 19. Patients who were already enrolled in other clinical studies; 20. Mixed lung cancer with small cell components.
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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
-
Peking University Cancer Hospital and Institute
Beijing, 100142, China
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Other studies related to the condition(s) this trial covers.
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