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Locally Advanced Non-Small Cell Lung CancerPhase 3NCT07052669

Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC

A Phase 3 study testing Hypofractionated Radiation Therapy, Conventionally Fractionated Radiation Therapy and Concurrent Chemotherapy in people with Locally Advanced Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 sites 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
Search all trials

Trial summary

Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Hypofractionated Radiation Therapy, Conventionally Fractionated Radiation Therapy and Concurrent Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
311 participants
Where
3 sitesChina
Study dates
1 Jul 2025to 30 Jun 2029
Phase
Phase 3
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

  • Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.
  • Age Range: Male or female patients aged 18 to 75 years.
  • Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.
  • Previous Treatment: Treatment-naïve or previously treated with induction chemotherapy ± immunotherapy.
  • Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived.
  • Driver gene testing: EGFR wild-type, ALK rearrangement-negative.
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  • Life Expectancy: Patients must have an expected survival of at least 12 weeks.
  • Performance Status (PS): The patient's WHO Performance Status (PS) must be 0 or 1.
  • Pregnancy Testing: Postmenopausal women, or women who have had a negative urine or serum pregnancy test within 14 days before the study medication (HCG sensitivity ≥ 25 IU/L or equivalent).
  • Breastfeeding: Women must not be breastfeeding.
  • Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment period and for 5 months after the last dose of the investigational drug (i.e., 30 days [ovulation cycle] + approximately 5 half-lives of the study drug).
  • Men who have sexual relations with WOCBP must agree to use contraception during the study treatment period and for 7 months after the last dose of the investigational drug (i.e., 90 days [sperm renewal cycle] + approximately 5 half-lives of the study drug).
  • Males with no sperm production are exempt from contraception requirements. WOCBP who are not sexually active are exempt from contraception but must still undergo pregnancy testing as outlined above.
  • Organ and Bone Marrow Function: The following laboratory parameters must be met:
  • Forced expiratory volume in 1 second (FEV1) ≥ 800 mL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelets ≥ 100 × 10⁹/L Hemoglobin ≥ 9.0 g/dL Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 50 mL/min Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN

Who cannot join

  • Patients meeting any of the following criteria should not be enrolled in the study:
  • Concurrent participation in another clinical trial, except for observational (non-interventional) studies.
  • Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg/day of prednisone or equivalent.
  • Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).
  • History or active autoimmune diseases within the past two years.
  • Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
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  • History of primary immunodeficiency.
  • History of organ transplantation requiring immunosuppressive therapy.
  • Average corrected QT interval (QTc) ≥470 ms calculated from three ECG cycles using the Bazett formula.
  • Uncontrolled comorbidities, including but not limited to: Persistent or active infections. Symptomatic congestive heart failure. Poorly controlled hypertension. Unstable angina. Cardiac arrhythmias. Active peptic ulcer disease or gastritis. Active bleeding disorders. Hepatitis C or HIV infection. HBsAg-positive patients with HBV DNA >500 IU/mL. Mental or social conditions that may limit adherence to study requirements or compromise the ability to provide informed consent.
  • Known history of tuberculosis.
  • Receipt of a live attenuated vaccine within 30 days before study initiation or planned during the study period.
  • History of another primary malignancy within the past 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.
  • Pregnancy, breastfeeding, or not using effective contraception (for men and women of reproductive potential).
  • Patients in the experimental group should not proceed to concurrent chemoradiotherapy if any of the following criteria are met:
  • Presence of distant metastases.
  • Locoregional progression making definitive concurrent chemoradiotherapy unfeasible due to normal tissue dose constraints (assessed by the radiation oncologist).
  • WHO performance status score of 2-4.
  • Impaired organ or bone marrow function, including:
  • Forced expiratory volume in 1 second (FEV1) <800 mL. Absolute neutrophil count (ANC) <1.5 × 10⁹/L. Platelets <100 × 10⁹/L. Hemoglobin <9.0 g/dL. Creatinine clearance (Cockcroft-Gault formula) <50 mL/min. Serum bilirubin >1.5 × upper limit of normal (ULN). AST and ALT >2.5 × ULN.
  • Patient withdrawal from the study.
  • Patients should not proceed to consolidation immunotherapy if any of the following criteria are met:
  • Disease progression during concurrent chemoradiotherapy.
  • Use of immunosuppressive drugs within 28 days before the first dose of tislelizumab, except for physiological doses of intranasal or inhaled corticosteroids or systemic corticosteroids ≤10 mg/day of prednisone or equivalent. Use of corticosteroids to manage chemoradiotherapy-related toxicity is permitted.
  • Persistent unresolved CTCAE grade >2 toxicities from prior chemoradiotherapy.
  • Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.
  • Any prior grade ≥3 immune-related adverse event (irAE) or unresolved irAE > grade 1.

Trial locations and contacts

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

Bo Qiu, Professor contact

02087343031

qiubo@sysucc.org.cn

Hui Liu, Professor contact

02087343031

liuhui@sysucc.org.cn

China3 sites, 3 recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Tao Zhang, MD, tumorzzt@163.com

    Recruiting

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Hui Liu, MD, 02087343031, liuhuisysucc@126.com

    Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

    Shihong Wei, M.Med, taonayongheng@126.com

    Recruiting

Other trials in China

About this study

Official title: Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study

Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.

Read the detailed description

This phase III, randomized controlled trial aims to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients. Patients will be randomized in a 2:1 ratio to the following two groups: (1) Study group: Patients in this group will undergo hypofractionated chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months. (2) Control group: Patients in this group will receive conventional fractionated chemoradiotherapy followed by consolidative immunotherapy for a maximum duration of 12 months.

Being tested
Hypofractionated Radiation Therapy, Conventionally Fractionated Radiation Therapy, Concurrent Chemotherapy, Consolidative immunotherapy
Keywords
Hypofractionated radiotherapy, Conventionally fractionated radiotherapy, Concurrent Chemoradiotherapy, Consolidative immunotherapy

What participants receive

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

  • Hypofractionated Radiation TherapyRadiation

    All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 ~2400 cGy in 5~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.

  • Conventionally Fractionated Radiation TherapyRadiation

    Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.

  • Concurrent ChemotherapyDrug

    Paclitaxel plus platinum-based chemotherapy.

  • concurrent chemotherapyDrug

    Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.

  • Consolidative immunotherapyDrug

    Following the completion of chemoradiotherapy, PD-1/PD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.

Study groups in NCT07052669
Study groupRoleWhat they receive
Hypofractionated CCRTExperimentalAll patients will receive hypofractionated concurrent chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.
Receives: Radiation: Hypofractionated Radiation Therapy; Drug: Concurrent Chemotherapy; Drug: Consolidative immunotherapy
Conventional fractionated CCRTActive comparatorAll patients will receive conventional fractionated concurrent chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.
Receives: Radiation: Conventionally Fractionated Radiation Therapy; Drug: concurrent chemotherapy; Drug: Consolidative immunotherapy

What is being measured

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

  1. Median Progression-Free Survival

    PFS measures the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.

    Measured: 2 years

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR refers to the proportion of patients who experience complete response (CR) and partial response (PR)

    Measured: 1-2 months after treatment

  2. Overall survival (OS)

    OS is the time from the start of treatment until death from any cause.

    Measured: 2 years

  3. Failure patterns

    Failure patterns describe the pattern of disease progression or treatment failure, such as local recurrence or distant metastases.

    Measured: 2 years

  4. Safety: Adverse Events

    Safety endpoints assess the frequency and severity of treatment-related adverse events. Adverse events are graded on a scale from 1 to 5 according to CTCAE 5.0.

    Measured: 1 years after treatment

  5. Quality of life assessed by Quality of Life Core 30

    Patient-reported quality of life measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores on functioning scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.

    Measured: 1 years after treatment

  6. Quality of life assessed by Quality of Life LC13

    Patient-reported quality of life measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC13). Higher scores on functioning scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.

    Measured: 1 years after treatment

Timeline

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

  1. First posted6 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
311 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052669
Sponsor's protocol ID
GASTO-10134
Status last verified
Jul 2025
First submitted
30 Jun 2025
Last updated
23 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou R, Liu F, Zhang H, Wang D, Zhang P, Zheng S, Liu Y, Chen L, Guo J, Zou Y, Rong YM, Liu H, Qiu B. Fraction Dose Escalation of Hypofractionated Radiotherapy with Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-Small Cell Lung Cancer: A Phase I Study. Clin Cancer Res. 2024 Jul 1;30(13):2719-2728. doi: 10.1158/1078-0432.CCR-23-3600.

    PubMed 38652815

  • Filatenkov A, Baker J, Mueller AM, Kenkel J, Ahn GO, Dutt S, Zhang N, Kohrt H, Jensen K, Dejbakhsh-Jones S, Shizuru JA, Negrin RN, Engleman EG, Strober S. Ablative Tumor Radiation Can Change the Tumor Immune Cell Microenvironment to Induce Durable Complete Remissions. Clin Cancer Res. 2015 Aug 15;21(16):3727-39. doi: 10.1158/1078-0432.CCR-14-2824. Epub 2015 Apr 13.

    PubMed 25869387

  • Lee Y, Auh SL, Wang Y, Burnette B, Wang Y, Meng Y, Beckett M, Sharma R, Chin R, Tu T, Weichselbaum RR, Fu YX. Therapeutic effects of ablative radiation on local tumor require CD8+ T cells: changing strategies for cancer treatment. Blood. 2009 Jul 16;114(3):589-95. doi: 10.1182/blood-2009-02-206870. Epub 2009 Apr 6.

    PubMed 19349616

  • Tang C, Liao Z, Gomez D, Levy L, Zhuang Y, Gebremichael RA, Hong DS, Komaki R, Welsh JW. Lymphopenia association with gross tumor volume and lung V5 and its effects on non-small cell lung cancer patient outcomes. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1084-1091. doi: 10.1016/j.ijrobp.2014.04.025. Epub 2014 Jul 8.

    PubMed 25035212

  • Wild AT, Herman JM, Dholakia AS, Moningi S, Lu Y, Rosati LM, Hacker-Prietz A, Assadi RK, Saeed AM, Pawlik TM, Jaffee EM, Laheru DA, Tran PT, Weiss MJ, Wolfgang CL, Ford E, Grossman SA, Ye X, Ellsworth SG. Lymphocyte-Sparing Effect of Stereotactic Body Radiation Therapy in Patients With Unresectable Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):571-9. doi: 10.1016/j.ijrobp.2015.11.026. Epub 2015 Dec 1.

    PubMed 26867885

  • Zhou R, Qiu B, Xiong M, Liu Y, Peng K, Luo Y, Wang D, Liu F, Chen N, Guo J, Zhang J, Huang X, Rong Y, Liu H. Hypofractionated Radiotherapy followed by Hypofractionated Boost with weekly concurrent chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Results of A Prospective Phase II Study (GASTO-1049). Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):387-399. doi: 10.1016/j.ijrobp.2023.04.021. Epub 2023 Apr 25.

    PubMed 37100160

  • Kong FM, Ten Haken RK, Schipper M, Frey KA, Hayman J, Gross M, Ramnath N, Hassan KA, Matuszak M, Ritter T, Bi N, Wang W, Orringer M, Cease KB, Lawrence TS, Kalemkerian GP. Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1358-1365. doi: 10.1001/jamaoncol.2017.0982.

    PubMed 28570742

  • Durm GA, Jabbour SK, Althouse SK, Liu Z, Sadiq AA, Zon RT, Jalal SI, Kloecker GH, Williamson MJ, Reckamp KL, Langdon RM, Kio EA, Gentzler RD, Adesunloye BA, Harb WA, Walling RV, Titzer ML, Hanna NH. A phase 2 trial of consolidation pembrolizumab following concurrent chemoradiation for patients with unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN 14-179. Cancer. 2020 Oct 1;126(19):4353-4361. doi: 10.1002/cncr.33083. Epub 2020 Jul 22.

    PubMed 32697352

  • Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2.

    PubMed 35108059

  • Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.

    PubMed 31622733

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

    PubMed 28885881

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypofractionated Radiation Therapy, Conventionally Fractionated Radiation Therapy and Concurrent Chemotherapy in people with Locally Advanced Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 sites 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 15 inclusion and 27 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Bo Qiu, Professor (02087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Progression-Free Survival (time frame: 2 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 NCT07052669, which also lists 11 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 23 Jul 2025.

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