Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

NCT06121505 | Recruiting Phase 2 DMC

• 1 other identifier: IHC-002
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 6

Brief Summary

This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer. There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.

Conditions

Lung Squamous Cell Carcinoma

Keywords

SBRT; Immunotherapy; LDRT; Lung Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  The proportion of subjects with complete response (CR) or partial response (PR) in the analyzed population as judged by the investigator according to RECIST v1.1 criteria. ORR = (number of subjects with CR + PR) / total number of subjects \* 100%.

  Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks (up to 24 months).

Secondary Outcomes (4)

• 6-month PFS rate

  From date of randomization to 6 months.

• 1-year PFS rate

  From date of randomization to 1 years.

• overall survival(OS)

  From date of randomization to the time when the subject died from any cause, assessed up to 36 months.

• Progression-free survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Study Arms (2)

Radiotherapy combined with sintilimab and chemotherapy

EXPERIMENTAL

Subjects received radiotherapy (SBRT+LDRT). Sintilimab combined with standard platinum-containing double-drug chemotherapy was performed within 1 week after the end of radiotherapy.

Radiation: low-dose radiation therapy and stereotactic body radiation therapy; Drug: chemotherapy; Drug: Sintilimab

Sintilimab+Chemotherapy

ACTIVE COMPARATOR

Subjects received sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles.

Drug: chemotherapy; Drug: Sintilimab

Interventions

low-dose radiation therapy and stereotactic body radiation therapy RADIATION

Patients will receive radiation therapy.

Also known as: RT

Radiotherapy combined with sintilimab and chemotherapy

Sintilimab DRUG

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).

Radiotherapy combined with sintilimab and chemotherapy; Sintilimab+Chemotherapy

chemotherapy DRUG

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).

Also known as: standard platinum-containing double-drug chemotherapy

Radiotherapy combined with sintilimab and chemotherapy; Sintilimab+Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old and ≤ 75 years old;
• 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);
• According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;
• Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;
• Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;

You may not qualify if:

• The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
• The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;
• EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
• 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;
• Pregnant or lactating women;

Sponsors & Collaborators

• Sichuan University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (6)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hunan, 430022, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610044, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637503, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40887121 DERIVED

MeSH Terms

Interventions

Radiotherapy; Radiosurgery; Drug Therapy; sintilimab

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• You Lu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxin Xue, MD

CONTACT

+86 189 8225 1798; killercell@163.com

You Lu, MD

CONTACT

+86 189 8060 1763; radyoulu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Division of Thoracic Tumor Multimodality Treatment

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 8, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)