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A prospective phase II single-arm clinical study on the efficacy and safety of tislelizumab combined with induction chemotherapy + concurrent chemoradiotherapy + maintenance therapy in patients with stage III unresectable non-small cell lung cancer (NSCLC)

A prospective phase II single-arm clinical study on the efficacy and safety of tislelizumab combined with induction chemotherapy + concurrent chemoradiotherapy + maintenance therapy in patients with stage III unresectable non-small cell lung cancer (NSCLC)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058342
Enrollment
Unknown
Registered
2022-04-07
Start date
2022-04-10
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Experimental group:Tirelizumab combined with chemotherapy induction therapy + concurrent chemoradiotherapy + tirelizumab

Sponsors

Xiamen Humanity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily joined the study and signed the informed consent; 2. Patients aged >=18 years, no gender limit; 3. Histologically or cytologically confirmed, untreated, inoperable stage IIIA, IIIB, or IIIC non-small cell lung cancer Stage 8 with at least one measurable lesion (according to RECIST v1.1 criteria); 4. Normal organ function; 5. Forced expiratory volume in the first second (FEV1) is greater than 50% of the expected normal value; 6. The diffusion capacity of carbon monoxide lung exceeds 40% of the expected normal value; 7. Cytological or histological tumor tissue specimens can be provided; 8. Whole body positron emission tomography, computed tomography, high diagnostic quality computed tomography and brain imaging showed no evidence of metastatic lesions; 9. ECOG score: 0-1; 10. The major organs are functioning normally.

Exclusion criteria

Exclusion criteria: 1. Past receipt of antibodies or drugs targeting the immune checkpoint pathway, including but not limited to anti-PD-1, anti-PD-L1, or anti-cytotoxic T lymphocyte-associated antigen 4(anti-CTLA-4) antibodies; 2. Treatment with systemic immunomodulators (including but not limited to interferon, interleukin 2, tumor necrosis factor) within the first 4 weeks of enrollment or within the 5 half-lives of the drug, whichever is older (cancer vaccines are allowed in previous treatment); 3. Patients with known positive driver genes such as EGFR and ALK; 4. Medical history and complications: The patient was enrolled in another clinical study, had received chemotherapy, radiation, or other antitumor agents within 4 weeks prior to the first dose of the investigational drug, had an active known or suspected autoimmune disease, had severe cardiovascular disease, had a history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, and had a known history of severe hypersensitivity to other monoclonal antibodies.

Design outcomes

Primary

MeasureTime frame
1-year progression-free survival rate;

Secondary

MeasureTime frame
1 year overall survival rate;Objective response rate;

Countries

China

Contacts

Public ContactHuang Cheng
Cheng671@sina.com+86 13905010379

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026