Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
NCT ID: NCT06121505
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
114 participants
INTERVENTIONAL
2024-03-01
2027-02-28
Brief Summary
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There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiotherapy combined with sintilimab and chemotherapy
Subjects received radiotherapy (SBRT+LDRT). Sintilimab combined with standard platinum-containing double-drug chemotherapy was performed within 1 week after the end of radiotherapy.
low-dose radiation therapy and stereotactic body radiation therapy
Patients will receive radiation therapy.
chemotherapy
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Sintilimab
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Sintilimab+Chemotherapy
Subjects received sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles.
chemotherapy
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Sintilimab
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Interventions
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low-dose radiation therapy and stereotactic body radiation therapy
Patients will receive radiation therapy.
chemotherapy
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Sintilimab
Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);
3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;
4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;
5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;
Exclusion Criteria
2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;
3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;
5. Pregnant or lactating women;
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Sichuan University
OTHER
Responsible Party
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You Lu
Chair of Division of Thoracic Tumor Multimodality Treatment
Principal Investigators
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You Lu, MD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hunan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang R, Chen M, Yin N, Xue J. Low-dose radiation and stereotactic body radiotherapy with PD-1 inhibitor sintilimab and chemotherapy for first-line treatment of locally advanced or metastatic squamous lung cancer: protocol for a randomised phase II trial (IHC002 study). BMJ Open. 2025 Aug 31;15(8):e094859. doi: 10.1136/bmjopen-2024-094859.
Other Identifiers
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IHC-002
Identifier Type: -
Identifier Source: org_study_id