Actively Recruiting
Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC
Led by Peking University Cancer Hospital & Institute · Updated on 2025-02-27
63
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large fractionated radiotherapy with a total dose of 48Gy/16 fractions, 3Gy per fraction, 5 days a week. Participants will receive two cycles of concurrent platinum-based doublet chemotherapy and concurrent immunotherapy. Patients without progression will receive consolidation immunotherapy. The maximum duration of immunotherapy is 24 months.
CONDITIONS
Official Title
Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before trial procedures
- Age between 18 and 70 years, any gender
- Histologically or cytologically confirmed inoperable locally advanced NSCLC (stage IIB-IIIC)
- No distant metastases (non-stage IV NSCLC) confirmed by imaging
- PD-L1 tumor proportion score of 20% or higher on quality-controlled tumor tissue
- At least one measurable lesion according to RECIST 1.1
- No prior treatment for advanced/metastatic NSCLC (except systemic neoadjuvant or induction therapies for stage IIB-IIIC NSCLC)
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
- Adequate organ function by laboratory tests
- Negative pregnancy test for women of childbearing potential within 3 days before first treatment
- Use of effective contraception during treatment and for 120 days after last dose (180 days after last chemotherapy dose) if pregnancy risk exists
You will not qualify if you...
- Diagnosis of small cell lung cancer or mixed tumors with small cell components
- Known sensitive mutations in EGFR, ALK, or ROS-1 genes
- Cavitary squamous carcinoma or imaging showing large vessel invasion
- History of active hemoptysis within 2 weeks prior to treatment
- Planned radiotherapy where normal lung tissue receiving >20 Gy exceeds 34%
- Prior chest radiotherapy before first dose
- Major surgery within 3 weeks prior to first dose (except biopsy or vascular access)
- Other malignancies within 5 years except certain skin cancers and carcinoma in situ
- Participation in other clinical trials or investigational treatments within 4 weeks before first dose
- Use of anti-lung cancer or immune-modulating traditional Chinese medicine within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before first dose (physiological doses allowed)
- Inability to discontinue certain medications with pemetrexed or refusal of required supplements
- History of organ transplantation (except corneal) or allogeneic hematopoietic stem cell transplantation
- Allergies to study drug components
- History of bleeding disorders or use of certain anticoagulants
- Severe thromboembolic events within 6 months prior to first dose
- Unresolved toxicities from previous treatments above grade 1 (excluding fatigue or hair loss)
- HIV infection
- Untreated active hepatitis B or C infection
- Receipt of live vaccines within 30 days prior to first dose
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases
- Any other condition that may interfere with study participation or results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, China
Actively Recruiting
Research Team
H
Huiming Yu
CONTACT
Y
Yue Teng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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