Lung CancerPhase 2NCT06877299
Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer
A Phase 2 study testing Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT) in people with Lung Cancer and Non-small Cell Lung Cancer, run by Sichuan University at 1 site in China.
Trial summary
This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 1 Jan 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years;
- Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);
- Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
- At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.
Who cannot join
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
- Patients with known EGFR-sensitive mutations or ALK fusion.
- 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;
- Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
- Active infection requiring systemic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, China, 610041
Jianxin Xue, MD. PhD, 18982251798, killercell@163.com
About this study
Official title: Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients With Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer
This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.
Read the detailed description
All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.
Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
- Keywords
- Neoadjuvant, Low Dose Radiotherapy, Stereotactic Body Radiotherapy, Immunotherapy, NSCLC
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)Drug
Also called Drug: Tislelizumab, Drug: Chemotherapy
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy combined with PD-1 inhibitor and chemotherapy group | Experimental | Low-Dose Radiation(2Gy*2-3d) +Stereotactic body radiation therapy (10Gy*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 3 cycles before surgical resection. Receives: Drug: Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin stained slides of the resected lung specimen and lymph nodes following completion of neoadjuvant therapy
Measured: From date of enrollment until one month after resection
Secondary outcomes (3)
MPR rate
mPR is defined as ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes.
Measured: From date of enrollment until one month after resection
R0-resection rate
Measured: From date of enrollment until one month after resection
Event-free survival (EFS)
EFS is defined as the time from enrollment to radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start4 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You Lu, Sichuan University
- Investigators
- You Lu, MD. PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877299
- Sponsor's protocol ID
- IHC-003
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.
PubMed 39305910Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.
PubMed 39581197Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
PubMed 35403841Zhou X, Zhou L, Yao Z, Huang M, Gong Y, Zou B, Zhu J, Liu Y, Peng F, Zhang Y, Yu M, Li Y, Na F, Wu Y, Kang K, Xiu W, Zhang X, Zhou L, Xu Y, Wang J, Wang Y, Yang X, Wu Y, Li R, Zhang Y, Yang Z, Zhou Z, Bai J, Yi X, Tong R, Yin L, Chen C, Niedermann G, Lu Y, Xue J. Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small Cell Lung Cancer Patients. Clin Cancer Res. 2023 Oct 13;29(20):4098-4108. doi: 10.1158/1078-0432.CCR-23-0315.
PubMed 37581611Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.
PubMed 32417411
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients With Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06877299
- Acronym / sponsor ID
- IHC-003
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- Neoadjuvant, Low Dose Radiotherapy, Stereotactic Body Radiotherapy, Immunotherapy, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Mar 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.
This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.
Detailed description
All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.
Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy combined with PD-1 inhibitor and chemotherapy group | Experimental | Drug: Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)Low-Dose Radiation(2Gy*2-3d) +Stereotactic body radiation therapy (10Gy*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 3 cycles before surgical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 75 years;
- Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);
- Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
- At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.
Key exclusion criteria (5 listed)
- The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
- Patients with known EGFR-sensitive mutations or ALK fusion.
- 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;
- Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
- Active infection requiring systemic treatment.
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 |
|---|---|---|
| Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)Also: Drug: Tislelizumab, Drug: ChemotherapyLow-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT) | Drug | Radiation therapy combined with PD-1 inhibitor and chemotherapy group |
Primary outcome
pCR rate
Time frame: From date of enrollment until one month after resection
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin stained slides of the resected lung specimen and lymph nodes following completion of neoadjuvant therapy
3 secondary outcomes
MPR rate
Time frame: From date of enrollment until one month after resection
R0-resection rate
Time frame: From date of enrollment until one month after resection
Event-free survival (EFS)
Time frame: up to 2 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 2 Jan 2026.
- Background: PubMed 39305910Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.
- Background: PubMed 39581197Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.
- Background: PubMed 35403841Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
- Results publication: PubMed 37581611Zhou X, Zhou L, Yao Z, Huang M, Gong Y, Zou B, Zhu J, Liu Y, Peng F, Zhang Y, Yu M, Li Y, Na F, Wu Y, Kang K, Xiu W, Zhang X, Zhou L, Xu Y, Wang J, Wang Y, Yang X, Wu Y, Li R, Zhang Y, Yang Z, Zhou Z, Bai J, Yi X, Tong R, Yin L, Chen C, Niedermann G, Lu Y, Xue J. Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small Cell Lung Cancer Patients. Clin Cancer Res. 2023 Oct 13;29(20):4098-4108. doi: 10.1158/1078-0432.CCR-23-0315.
- Results publication: PubMed 32417411Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.
- Individual participant dataSharing planned: No
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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.
You Lu, MD. PhD principal investigator
Study Principal Investigator
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 Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT) in people with Lung Cancer and Non-small Cell Lung Cancer, run by Sichuan University 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 5 inclusion and 5 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 2 Jan 2026. 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 Jianxin Xue, MD. Phd (18982251798, killercell@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: From date of enrollment until one month after resection). 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 NCT06877299, which also lists 5 linked publications.
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 2 Jan 2026.