Non-Small Cell Lung CancerPhase 2NCT06849167

Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in LA-NSCLC

A Phase 2 study testing hypofractionated radiotherapy with immunotherapy in people with Non-Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: hypofractionated radiotherapy with immunotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteChina
Study dates: 1 Mar 2025to 1 Mar 2030
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign a written informed consent before implementing any trial-related procedures.
Age ≥ 18 years and ≤ 70 years, male or female.
Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer 8th edition TNM lung cancer staging);
Notes:
If EBUS/EUS or mediastinoscopy can safely obtain samples from the hilar or mediastinal lymph nodes, it is encouraged to obtain tissue for confirmation of involvement. When the lymph node boundary is clear and at least one lymph node has a short axis ≥ 2.0 cm, lymph node involvement can be determined by imaging (CT/MRI scan). For lymph nodes with a short axis < 2.0 cm, if pathologically confirmed, the patient can be included in the study. If the primary tumor is deemed unresectable and mediastinal lymph node metastasis does not affect the radiotherapy plan, the patient can be included.
Determined and documented by a multidisciplinary tumor board or consultation with a thoracic surgeon: the patient has inoperable stage IIB-IIIC NSCLC.

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No evidence of distant metastatic disease on diagnostic quality CT or MRI scans of the chest, abdomen, pelvis, and brain and/or whole-body fluorodeoxyglucose (FDG)-PET/CT, and classified as non-IV stage NSCLC (i.e., M0).
Note: For pleural effusion present in both CT chest scan and frontal chest X-ray, a thoracentesis should be performed to confirm the pleural effusion is negative on cytology and is non-exudative. For patients who meet all other inclusion/exclusion criteria but are unable to undergo thoracentesis due to minimal pleural effusion, they may still be included in the study.
Provide a sufficient amount of quality-controlled tumor tissue or cell wax blocks for the pathology department of the study center to test PD-L1 expression using the 22C3 antibody, with a PD-L1 TPS ≥ 20%; or a pre-screening PD-L1 TPS ≥ 20% result (regardless of the antibody used, including 22C3, SP263, SP142).
At least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for use as a target lesion.
No prior treatment for advanced/metastatic NSCLC (chemotherapy, targeted therapy, immunotherapy, or radiotherapy). Patients who have previously received systemic induction or neoadjuvant therapy (chemotherapy, immunotherapy) for stage IIB-IIIC NSCLC and are about to receive curative concurrent chemoradiotherapy can be included in the study.
Patients who have previously received induction immunotherapy can be included, including the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another co-stimulatory or inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), immune LAG-3 inhibitors, and TIGIT monoclonal antibodies.
ECOG performance status of 0-1.
Life expectancy ≥ 6 months.
Adequate organ function, with the following laboratory parameters:
For women of childbearing potential, a negative urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential women are defined as those who are at least 1 year post-menopausal, surgically sterilized, or have undergone a hysterectomy.
If there is a risk of pregnancy, all participants (regardless of sex) must use a contraceptive method with a failure rate of less than 1% during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).

Who cannot join

Pathologically diagnosed small cell lung cancer (SCLC), or mixed tumors containing small cell components.
Have undergone genetic testing prior to enrollment and known to have sensitive mutations in EGFR, ALK, or ROS-1 genes.
Subjects evaluated by the investigator with cavitary squamous carcinoma or imaging suggesting large vessel invasion/infiltration, or those with a history of active hemoptysis (coughing up at least 1/2 teaspoon of fresh blood) within 2 weeks prior to the first dose of the study drug.
In the planned radiotherapy regimen, the volume of normal lung tissue (total lung - GTV) receiving a total radiation dose >20Gy may exceed 34%.
Have previously received any chest-directed radiotherapy (including esophagus, mediastinum, or breast cancer radiotherapy) before the first dose of the study drug.
Have undergone major surgery within 3 weeks prior to the first dose of the study drug (excluding surgeries for biopsy purposes or vascular access placement, but subjects must have fully recovered from treatment toxicities and/or complications).

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Have been diagnosed with a malignancy other than NSCLC within 5 years prior to the first dose (excluding surgically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or surgically resected carcinoma in situ).
Are currently participating in an interventional clinical trial or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose, or are expected to require any other form of anti-tumor treatment during the study.
Have received traditional Chinese medicine with anti-lung cancer indications or immune-modulating drugs (including thymosin, interferons, interleukins) as systemic treatment within 2 weeks prior to the first dose of the study drug.
Have had active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of the study drug. Alternative therapies (e.g., thyroid hormones, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatments.
Are receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of local glucocorticoid therapy) or any other form of immunosuppressive therapy within 7 days before the first dose of the study drug.
Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed.
Specific to pemetrexed: If aspirin or other NSAIDs cannot be discontinued for at least 2 days before, during, and 2 days after pemetrexed administration (except when daily aspirin dose is ≤1.3g), or the patient cannot or refuses to take folic acid, vitamin B12, and dexamethasone.
Have known history of organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
Have known allergies to any of the active ingredients or excipients of the study drugs, including PD-1/PD-L1 monoclonal antibodies, pemetrexed, injectable albumin-bound paclitaxel, paclitaxel, carboplatin, cisplatin, etc.
Have a history of bleeding tendencies (e.g., active gastrointestinal ulcers) or are receiving anticoagulants or vitamin K antagonists such as warfarin, heparin, or its analogs.
Note: Small-dose warfarin (≤1mg/day), low-dose heparin (≤12,000 U/day), or low-dose aspirin (≤100mg/day) may be used for prophylactic purposes if the international normalized ratio (INR) is ≤1.5.
Have experienced severe arterial/venous thromboembolic events (e.g., cerebrovascular accident, including transient ischemic attacks, deep vein thrombosis, or pulmonary embolism) within 6 months prior to the first dose.
Have not fully recovered from any toxicity and/or complications from previous interventions (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss).
Have a known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive).
Have untreated active hepatitis B (defined as HBsAg positive and HBV-DNA levels exceeding the upper normal limit at the local center's laboratory).
Note: The following hepatitis B patients may be included:
HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, provided they receive anti-HBV treatment throughout the study period to prevent viral reactivation.
Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have HBV viral load (-) do not need prophylactic anti-HBV treatment but should be closely monitored for viral reactivation.
Have active HCV infection (HCV antibody positive with HCV-RNA levels above the detection threshold).
Have received a live vaccine within 30 days prior to the first dose of the study drug (Day 1, Cycle 1).
Note: Inactivated seasonal influenza vaccines and COVID-19 vaccines for prevention are allowed within 30 days prior to the first dose, but live attenuated influenza vaccines administered intranasally are not permitted.
Are pregnant or breastfeeding women.
Have any severe or uncontrolled systemic diseases
Any other medical history or evidence of disease, treatment, or abnormal laboratory findings that may interfere with the study results or hinder participation, or any other conditions deemed unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huiming Yu contact

010-8819 6984

huiming740512@126.com

Yue Teng contact

86-15910501617

tengyue1116@126.com

China1 site, 1 recruiting

Peking University Cancer Hospital & Institute
Beijing
Teng, 86-15910501617, tengyue1116@126.com
Recruiting

Other trials in China

About this study

Official title: A Single-Arm Phase II Clinical Trial of Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer

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: Non-Small Cell Lung Cancer
Being tested: hypofractionated radiotherapy with immunotherapy
Keywords: Immunotherapy, Non-Small Cell Lung Cancer, hypofractionated radiotherapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hypofractionated radiotherapy with immunotherapyRadiation
Immunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy

Study groups in NCT06849167
Study group	Role	What they receive
hypofractionated group	Experimental	Immunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy Receives: Radiation: hypofractionated radiotherapy with immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

PFS
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first
Measured: through study completion, an average of 3 years

Secondary outcomes (7)

ORR
The proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response following treatment initiation, relative to the total number of subjects.
Measured: through study completion, an average of 3 years
DCR
The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) as their best overall response following treatment initiation, relative to the total number of subjects.
Measured: through study completion, an average of 3 years
DOR
Time interval from the first documented evidence of response (CR or PR) to disease progression or death (whichever occurs first).
Measured: through study completion, an average of 3 years
OS
Time from subject enrollment to death from any cause.
Measured: through study completion, an average of 3 years
HRQoL Assessment:
The "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items" (EORTC QLQ-C30) will be used to evaluate subjects' global health status.
Measured: through study completion, an average of 3 years
Safety Evaluation
Adverse events (AEs) occurring during the study and follow-up period will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Safety evaluation metrics include:
Incidence, severity, and relationship to study treatment of all adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Number and proportion of subjects discontinuing treatment due to the above adverse events;
Measured: through study completion, an average of 3 years
Economic Evaluation
Cost-effectiveness of medical interventions will be assessed using metrics such as the Incremental Cost-Effectiveness Ratio (ICER) and Quality-Adjusted Life Years (QALYs).
Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20251 Mar 2030

First posted27 Feb 2025
Study start1 Mar 2025 (estimated)
Primary completion1 Mar 2029 (estimated)
Study completion1 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06849167
Sponsor's protocol ID: LGH2024453
Status last verified: Feb 2025
First submitted: 17 Feb 2025
Last updated: 27 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm Phase II Clinical Trial of Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immunotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06849167
Acronym / sponsor ID: LGH2024453
Conditions: Non-Small Cell Lung Cancer
Keywords: Immunotherapy, Non-Small Cell Lung Cancer, hypofractionated radiotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 63 participants (estimated)
Lead sponsor: Peking University Cancer Hospital & InstituteUniversity, hospital or other
Study start: 1 Mar 2025 (estimated)
Primary completion: 1 Mar 2029 (estimated)
Study completion: 1 Mar 2030 (estimated)
First posted: 27 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
hypofractionated group	Experimental	Radiation: hypofractionated radiotherapy with immunotherapyImmunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Sign a written informed consent before implementing any trial-related procedures.
Age ≥ 18 years and ≤ 70 years, male or female.
Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer 8th edition TNM lung cancer staging);
No evidence of distant metastatic disease on diagnostic quality CT or MRI scans of the chest, abdomen, pelvis, and brain and/or whole-body fluorodeoxyglucose (FDG)-PET/CT, and classified as non-IV stage NSCLC (i.e., M0).
Note: For pleural effusion present in both CT chest scan and frontal chest X-ray, a thoracentesis should be performed to confirm the pleural effusion is negative on cytology and is non-exudative. For patients who meet all other inclusion/exclusion criteria but are unable to undergo thoracentesis due to minimal pleural effusion, they may still be included in the study.

Key exclusion criteria (30 listed)

Pathologically diagnosed small cell lung cancer (SCLC), or mixed tumors containing small cell components.
Have undergone genetic testing prior to enrollment and known to have sensitive mutations in EGFR, ALK, or ROS-1 genes.
Subjects evaluated by the investigator with cavitary squamous carcinoma or imaging suggesting large vessel invasion/infiltration, or those with a history of active hemoptysis (coughing up at least 1/2 teaspoon of fresh blood) within 2 weeks prior to the first dose of the study drug.
In the planned radiotherapy regimen, the volume of normal lung tissue (total lung - GTV) receiving a total radiation dose >20Gy may exceed 34%.
Have previously received any chest-directed radiotherapy (including esophagus, mediastinum, or breast cancer radiotherapy) before the first dose of the study drug.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hypofractionated radiotherapy with immunotherapyImmunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy	Radiation	hypofractionated group

Primary outcome

PFS
Time frame: through study completion, an average of 3 years
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first

7 secondary outcomes

ORR
Time frame: through study completion, an average of 3 years
DCR
Time frame: through study completion, an average of 3 years
DOR
Time frame: through study completion, an average of 3 years
OS
Time frame: through study completion, an average of 3 years
HRQoL Assessment:
Time frame: through study completion, an average of 3 years
Safety Evaluation
Time frame: through study completion, an average of 3 years
Economic Evaluation
Time frame: through study completion, an average of 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Huiming Yu contact

010-8819 6984

huiming740512@126.com

Yue Teng contact

86-15910501617

tengyue1116@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hypofractionated radiotherapy with immunotherapy in people with Non-Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huiming Yu (010-8819 6984, huiming740512@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06849167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.