Non-Small Cell Lung CancerPhase 2NCT07014202
Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy
A Phase 2 study testing Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy and Immunotherapy (with or without chemotherapy) maintenance therapy in people with Non-Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy and Immunotherapy (with or without chemotherapy) maintenance therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2025to 1 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signed written informed consent and compliance with protocol requirements;
- Age ≥ 18 years;
- Expected survival time ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically or cytologically confirmed advanced non-small cell lung cancer;
- After receiving 4-6 cycles of first-line platinum-based chemotherapy combined with immunotherapy, PET-CT evaluation shows no disease progression, with no more than 5 lesions not meeting criteria for complete metabolic response, involving no more than 3 organs;
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- All residual lesions can safely receive radiation therapy as assessed by radiation oncologists;
- Patient can tolerate the radiotherapy process, such as maintaining fixed position;
- At least one measurable lesion among the oligoresidual lesions according to RECIST v1.1;
- Agreement to provide archived tumor tissue specimens from primary or metastatic sites, or fresh tissue samples; if unable to provide tumor tissue samples, subjects may be enrolled after investigator assessment if meeting other inclusion/exclusion criteria;
- Toxicities from previous anti-tumor therapies recovered to ≤ grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) (excluding alopecia, fatigue, pigmentation, hypothyroidism stable on hormone replacement therapy, grade 2 peripheral neuropathy after chemotherapy, and exceptions specified in other inclusion criteria);
- Laboratory values at screening must meet the following criteria: a) Neutrophils ≥ 1.5×10^9/L b) Platelets ≥ 100×10^9/L c) Hemoglobin ≥ 90g/L (no blood transfusion within 14 days) d) Serum Cr ≤ 1×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula) e) AST ≤ 2.5×ULN; ALT ≤ 2.5×ULN; if liver metastases present, ALT and AST ≤ 5×ULN f) Total bilirubin ≤ 1.5×ULN (except for Gilbert's syndrome subjects, where total bilirubin must be < 51.3μmol/L) g) Thyroid Stimulating Hormone (TSH), Free Triiodothyronine (FT3), Free Thyroxine (FT4) all within ±10% of normal range.
Who cannot join
- Archived tumor tissue, pre-treatment tumor biopsy, or histological examination showing evidence of previous small cell or mixed small cell/non-small cell histology;
- Previous tissue samples or peripheral blood genetic sequencing reports indicating EGFR sensitizing mutations, ALK fusion, or other gene variations that should receive standard first-line targeted therapy; squamous cell carcinoma without genetic testing is presumed negative;
- Symptomatic brain metastases;
- Leptomeningeal metastases;
- Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to recur in the absence of external triggers);
- Active tuberculosis (TB) infection as determined by chest X-ray, sputum examination, and clinical examination. Patients with a history of active pulmonary TB infection within the previous year, even if treated, will be excluded. Patients with a history of active pulmonary TB infection more than 1 year ago will also be excluded unless effective previous anti-TB treatment can be documented;
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- Comorbidities requiring immunosuppressive medication, or requiring systemic or local use of corticosteroids at immunosuppressive doses;
- Pregnancy or breastfeeding;
- Interstitial lung disease with symptomatic manifestations, or that may interfere with the detection or management of suspected drug-related pulmonary toxicity;
- Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg positive and HBV-DNA > 10^3 copies/ml), or hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection at the research center);
- History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
- Receipt of other investigational drugs or treatments within 4 weeks prior to study randomization;
- Use of any Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study drug administration;
- History of other malignancies (excluding non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast), unless complete remission was achieved at least 2 years prior to study enrollment and no additional therapy is required or anticipated during the study period;
- History of severe cardiac or cerebrovascular disease, e.g., New York Heart Association (NYHA) ≥ class 2 heart failure, acute coronary syndrome (such as myocardial infarction, unstable angina, etc.) within 6 months of screening, acute cerebrovascular disease (such as transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) within 6 months of screening;
- Thromboembolic events requiring therapeutic intervention within 6 months prior to screening, such as unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism; excluding infusion-related thrombosis;
- Planned vaccination or vaccination with live vaccines within 28 days prior to study randomization;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator due to comorbidities or other circumstances.
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
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Zhijie, MD, +8613466323860, jie_969@163.com
About this study
Official title: Comparing Consolidation Radiotherapy Versus No Radiotherapy for Oligoresidual Disease After First-line Chemotherapy Plus Immunotherapy in Advanced Non-Small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial
This clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment.
The primary objective is to determine if adding targeted radiation therapy to residual lesions prolongs progression-free survival in NSCLC patients with "oligo-residual lesions" (5 or fewer tumors in no more than 3 organs) following first-line chemoimmunotherapy. Researchers hypothesize that combination therapy will slow cancer progression more effectively than maintenance therapy alone.
Read more
Eligible participants include adults (18+) with advanced NSCLC who have completed 4-6 cycles of first-line chemoimmunotherapy, show limited residual disease on Positron Emission Tomography-Computed Tomography (PET-CT), and lack specific genetic mutations (Epidermal Growth Factor Receptor [EGFR], Anaplastic Lymphoma Kinase [ALK], etc.).
Patients will be randomized into two groups:
Experimental: Continuation of maintenance therapy (immunotherapy alone or with chemotherapy) plus local radiotherapy to all residual tumors Control: Continuation of maintenance therapy only
The study aims to answer:
Primary: Does adding radiotherapy slow cancer progression more effectively? Secondary: Does it improve overall survival, control residual disease, and what are its effects on safety and quality of life?
Participants will:
Be randomly assigned to a treatment group Receive their designated treatment Undergo regular check-ups and imaging scans Complete quality of life questionnaires Potentially provide blood samples for research This research will help determine optimal treatment approaches for this specific patient population to improve outcomes and quality of life.
Read the detailed description
The purpose of this clinical study is to find out whether the addition of local radiation therapy (radiotherapy) after standard chemotherapy and immunotherapy is better than continuing maintenance therapy alone for patients with specific types of advanced lung cancer .
Study Objectives and Hypotheses:
The primary objective is to see if the addition of radiation therapy to target residual lesions will prolong the time that a patient's cancer does not get worse (progression-free survival) in patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of tumors (known as "oligo-residual lesions") after receiving first-line chemotherapy in combination with immunotherapy . The researchers hypothesized that patients who receive maintenance therapy plus radiation therapy will have their cancer progress more slowly than patients who receive only maintenance therapy .
Study Population:
This study is for adult patients 18 years of age and older who have been diagnosed with advanced non-small cell lung cancer . These patients have received 4 to 6 cycles of first-line chemotherapy in combination with immunotherapy and have a limited number of tumor lesions on post-treatment imaging (PET-CT) (no more than 5 residual lesions involving no more than 3 organs) and no specific genetic mutations (e.g., Epidermal Growth Factor Receptor [EGFR], Anaplastic Lymphoma Kinase [ALK], etc.).
Study Methods:
Eligible patients will be randomly assigned to one of two groups :
Experimental group: continuation of maintenance therapy (either immunotherapy or chemotherapy combined with immunotherapy, depending on the previous regimen) and local radiotherapy to all residual tumor lesions.
Control group: Continuation of maintenance therapy only.
Key questions to be answered by the study:
Primary question: is the addition of local radiotherapy more effective in slowing cancer progression than maintenance therapy alone in this group of lung cancer patients? Secondary questions include: Does the addition of radiotherapy prolong overall survival? How effective is it in controlling residual disease? What is the safety (side effects) of the treatment and how does it affect the patient's quality of life?
What participants need to do:
Be randomized to one of the treatment groups . Receive the appropriate treatment (maintenance therapy, or maintenance therapy plus radiotherapy) according to their group.
Have regular check-ups and imaging scans to assess the status of the tumor. Complete questionnaires about quality of life. May be asked to provide a blood sample for research . This study will help doctors to better understand how to treat this special group of patients with advanced lung cancer, with a view to improving their outcome and quality of life.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy, Immunotherapy (with or without chemotherapy) maintenance therapy
- 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.
Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapyCombination product
Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT.
Immunotherapy (with or without chemotherapy) maintenance therapyDrug
Immunotherapy (with or without chemotherapy) maintenance therapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance therapy combined with radiotherapy group | Experimental | Radiotherapy Protocol:
Target all residual primary lesions and all metastatic sites (pulmonary, hepatic, osseous, lymphadenopathy). Fractionation determined by treating physician after multidisciplinary consultation. For lesions near critical organs, appropriate fractionation/total doses selected per clinical situation.
Maintenance Therapy Protocol:
Based on latest National Comprehensive Cancer Network (NCCN)/Chinese Society of Clinical Oncology(CSCO) guidelines for stage IV non-small cell lung cancer (NSCLC). For lung adenocarcinoma: Following 4-6 cycles of first-line therapy (pemetrexed+platinum+immunotherapy) Maintenance: Pemetrexed (500mg/m²) + pembrolizumab 200mg IV q3w. Duration: Maximum 24 months (until week 96, disease progression, unacceptable toxicity, consent withdrawal, or other termination criteria). All trial patients receive immunotherapy maintenance Receives: Combination Product: Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy |
| Maintenance therapy | Active comparator | Based on latest NCCN/CSCO guidelines for stage IV NSCLC. For lung adenocarcinoma: Following 4-6 cycles of first-line therapy (pemetrexed+platinum+immunotherapy) Maintenance: Pemetrexed (500mg/m²) + pembrolizumab 200mg IV q3w. Duration: Maximum 24 months (until week 96, disease progression, unacceptable toxicity, consent withdrawal, or other termination criteria). All trial patients receive immunotherapy maintenance Receives: Drug: Immunotherapy (with or without chemotherapy) maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from randomization (with or without radiotherapy) to first occurrence of objective disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or death from any cause (if occurring before disease progression).
Measured: The estimated median PFS time from entry into maintenance therapy to recurrence in the control group is 6 months. The experimental group is expected to extend median PFS time from 6 months to 8.7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start11 Jun 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Zhijie Wang, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014202
- Sponsor's protocol ID
- NCC4839
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Gao S, Li N, Wang S, Zhang F, Wei W, Li N, Bi N, Wang Z, He J. Lung Cancer in People's Republic of China. J Thorac Oncol. 2020 Oct;15(10):1567-1576. doi: 10.1016/j.jtho.2020.04.028. No abstract available.
PubMed 32981600Cheng Y, Zhang T, Xu Q. Therapeutic advances in non-small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy. MedComm (2020). 2021 Dec 14;2(4):692-729. doi: 10.1002/mco2.105. eCollection 2021 Dec.
PubMed 34977873Zappa C, Mousa SA. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016 Jun;5(3):288-300. doi: 10.21037/tlcr.2016.06.07.
PubMed 27413711Parikh RB, Cronin AM, Kozono DE, Oxnard GR, Mak RH, Jackman DM, Lo PC, Baldini EH, Johnson BE, Chen AB. Definitive primary therapy in patients presenting with oligometastatic non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):880-7. doi: 10.1016/j.ijrobp.2014.04.007. Epub 2014 May 24.
PubMed 24867533Winegarden JD, Mauer AM, Otterson GA, Rudin CM, Villalona-Calero MA, Lanzotti VJ, Szeto L, Kasza K, Hoffman PC, Vokes EE; University of Chicago Phase II Network; Ohio State University. A phase II study of oxaliplatin and paclitaxel in patients with advanced non-small-cell lung cancer. Ann Oncol. 2004 Jun;15(6):915-20. doi: 10.1093/annonc/mdh215.
PubMed 15151948Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1.
PubMed 31908301Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.
PubMed 7799047Rim CH, Cho WK, Park S, Yoon WS, Yang DS. Role of local ablative treatment in oligometastatic non-small cell lung cancer: a meta-analysis. Int J Surg. 2023 Apr 1;109(4):1006-1014. doi: 10.1097/JS9.0000000000000339.
PubMed 36974686Dingemans AC, Hendriks LEL, Berghmans T, Levy A, Hasan B, Faivre-Finn C, Giaj-Levra M, Giaj-Levra N, Girard N, Greillier L, Lantuejoul S, Edwards J, O'Brien M, Reck M, Smit EF, Van Schil P, Postmus PE, Ramella S, Lievens Y, Gaga M, Peled N, Scagliotti GV, Senan S, Paz-Ares L, Guckenberger M, McDonald F, Ekman S, Cufer T, Gietema H, Infante M, Dziadziuszko R, Peters S, Porta RR, Vansteenkiste J, Dooms C, de Ruysscher D, Besse B, Novello S. Definition of Synchronous Oligometastatic Non-Small Cell Lung Cancer-A Consensus Report. J Thorac Oncol. 2019 Dec;14(12):2109-2119. doi: 10.1016/j.jtho.2019.07.025. Epub 2019 Aug 6.
PubMed 31398540Pawlik TM, Scoggins CR, Zorzi D, Abdalla EK, Andres A, Eng C, Curley SA, Loyer EM, Muratore A, Mentha G, Capussotti L, Vauthey JN. Effect of surgical margin status on survival and site of recurrence after hepatic resection for colorectal metastases. Ann Surg. 2005 May;241(5):715-22, discussion 722-4. doi: 10.1097/01.sla.0000160703.75808.7d.
PubMed 15849507Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.
PubMed 9011700Franceschini D, De Rose F, Cozzi S, Franzese C, Rossi S, Finocchiaro G, Toschi L, Santoro A, Scorsetti M. The use of radiation therapy for oligoprogressive/oligopersistent oncogene-driven non small cell lung cancer: State of the art. Crit Rev Oncol Hematol. 2020 Apr;148:102894. doi: 10.1016/j.critrevonc.2020.102894. Epub 2020 Feb 5.
PubMed 32062314Kordbacheh T, Honeychurch J, Blackhall F, Faivre-Finn C, Illidge T. Radiotherapy and anti-PD-1/PD-L1 combinations in lung cancer: building better translational research platforms. Ann Oncol. 2018 Feb 1;29(2):301-310. doi: 10.1093/annonc/mdx790.
PubMed 29309540Pitroda SP, Chmura SJ, Weichselbaum RR. Integration of radiotherapy and immunotherapy for treatment of oligometastases. Lancet Oncol. 2019 Aug;20(8):e434-e442. doi: 10.1016/S1470-2045(19)30157-3. Epub 2019 Jul 29.
PubMed 31364595
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Consolidation Radiotherapy Versus No Radiotherapy for Oligoresidual Disease After First-line Chemotherapy Plus Immunotherapy in Advanced Non-Small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07014202
- Acronym / sponsor ID
- NCC4839
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 10 Jun 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 clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment.
The primary objective is to determine if adding targeted radiation therapy to residual lesions prolongs progression-free survival in NSCLC patients with "oligo-residual lesions" (5 or fewer tumors in no more than 3 organs) following first-line chemoimmunotherapy. Researchers hypothesize that combination therapy will slow cancer progression more effectively than maintenance therapy alone.
Eligible participants include adults (18+) with advanced NSCLC who have completed 4-6 cycles of first-line chemoimmunotherapy, show limited residual disease on Positron Emission Tomography-Computed Tomography (PET-CT), and lack specific genetic mutations (Epidermal Growth Factor Receptor [EGFR], Anaplastic Lymphoma Kinase [ALK], etc.).
Patients will be randomized into two groups:
Experimental: Continuation of maintenance therapy (immunotherapy alone or with chemotherapy) plus local radiotherapy to all residual tumors Control: Continuation of maintenance therapy only
The study aims to answer:
Primary: Does adding radiotherapy slow cancer progression more effectively? Secondary: Does it improve overall survival, control residual disease, and what are its effects on safety and quality of life?
Participants will:
Be randomly assigned to a treatment group Receive their designated treatment Undergo regular check-ups and imaging scans Complete quality of life questionnaires Potentially provide blood samples for research This research will help determine optimal treatment approaches for this specific patient population to improve outcomes and quality of life.
Detailed description
The purpose of this clinical study is to find out whether the addition of local radiation therapy (radiotherapy) after standard chemotherapy and immunotherapy is better than continuing maintenance therapy alone for patients with specific types of advanced lung cancer .
Study Objectives and Hypotheses:
The primary objective is to see if the addition of radiation therapy to target residual lesions will prolong the time that a patient's cancer does not get worse (progression-free survival) in patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of tumors (known as "oligo-residual lesions") after receiving first-line chemotherapy in combination with immunotherapy . The researchers hypothesized that patients who receive maintenance therapy plus radiation therapy will have their cancer progress more slowly than patients who receive only maintenance therapy .
Study Population:
This study is for adult patients 18 years of age and older who have been diagnosed with advanced non-small cell lung cancer . These patients have received 4 to 6 cycles of first-line chemotherapy in combination with immunotherapy and have a limited number of tumor lesions on post-treatment imaging (PET-CT) (no more than 5 residual lesions involving no more than 3 organs) and no specific genetic mutations (e.g., Epidermal Growth Factor Receptor [EGFR], Anaplastic Lymphoma Kinase [ALK], etc.).
Study Methods:
Eligible patients will be randomly assigned to one of two groups :
Experimental group: continuation of maintenance therapy (either immunotherapy or chemotherapy combined with immunotherapy, depending on the previous regimen) and local radiotherapy to all residual tumor lesions.
Control group: Continuation of maintenance therapy only.
Key questions to be answered by the study:
Primary question: is the addition of local radiotherapy more effective in slowing cancer progression than maintenance therapy alone in this group of lung cancer patients? Secondary questions include: Does the addition of radiotherapy prolong overall survival? How effective is it in controlling residual disease? What is the safety (side effects) of the treatment and how does it affect the patient's quality of life?
What participants need to do:
Be randomized to one of the treatment groups . Receive the appropriate treatment (maintenance therapy, or maintenance therapy plus radiotherapy) according to their group.
Have regular check-ups and imaging scans to assess the status of the tumor. Complete questionnaires about quality of life. May be asked to provide a blood sample for research . This study will help doctors to better understand how to treat this special group of patients with advanced lung cancer, with a view to improving their outcome and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance therapy combined with radiotherapy group | Experimental | Combination Product: Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapyRadiotherapy Protocol: Target all residual primary lesions and all metastatic sites (pulmonary, hepatic, osseous, lymphadenopathy). Fractionation determined by treating physician after multidisciplinary consultation. For lesions near critical organs, appropriate fractionation/total doses selected per clinical situation. Maintenance Therapy Protocol: Based on latest National Comprehensive Cancer Network (NCCN)/Chinese Society of Clinical Oncology(CSCO) guidelines for stage IV non-small cell lung cancer (NSCLC). For lung adenocarcinoma: Following 4-6 cycles of first-line therapy (pemetrexed+platinum+immunotherapy) Maintenance: Pemetrexed (500mg/m²) + pembrolizumab 200mg IV q3w. Duration: Maximum 24 months (until week 96, disease progression, unacceptable toxicity, consent withdrawal, or other termination criteria). All trial patients receive immunotherapy maintenance |
| Maintenance therapy | Active comparator | Drug: Immunotherapy (with or without chemotherapy) maintenance therapyBased on latest NCCN/CSCO guidelines for stage IV NSCLC. For lung adenocarcinoma: Following 4-6 cycles of first-line therapy (pemetrexed+platinum+immunotherapy) Maintenance: Pemetrexed (500mg/m²) + pembrolizumab 200mg IV q3w. Duration: Maximum 24 months (until week 96, disease progression, unacceptable toxicity, consent withdrawal, or other termination criteria). All trial patients receive immunotherapy maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary signed written informed consent and compliance with protocol requirements;
- Age ≥ 18 years;
- Expected survival time ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically or cytologically confirmed advanced non-small cell lung cancer;
Key exclusion criteria (18 listed)
- Archived tumor tissue, pre-treatment tumor biopsy, or histological examination showing evidence of previous small cell or mixed small cell/non-small cell histology;
- Previous tissue samples or peripheral blood genetic sequencing reports indicating EGFR sensitizing mutations, ALK fusion, or other gene variations that should receive standard first-line targeted therapy; squamous cell carcinoma without genetic testing is presumed negative;
- Symptomatic brain metastases;
- Leptomeningeal metastases;
- Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to recur in the absence of external triggers);
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 |
|---|---|---|
| Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapyImmunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT. | Combination product | Maintenance therapy combined with radiotherapy group |
| Immunotherapy (with or without chemotherapy) maintenance therapyImmunotherapy (with or without chemotherapy) maintenance therapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT. | Drug | Maintenance therapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: The estimated median PFS time from entry into maintenance therapy to recurrence in the control group is 6 months. The experimental group is expected to extend median PFS time from 6 months to 8.7 months.
Time from randomization (with or without radiotherapy) to first occurrence of objective disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or death from any cause (if occurring before disease progression).
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 30 Jul 2025.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 32981600Gao S, Li N, Wang S, Zhang F, Wei W, Li N, Bi N, Wang Z, He J. Lung Cancer in People's Republic of China. J Thorac Oncol. 2020 Oct;15(10):1567-1576. doi: 10.1016/j.jtho.2020.04.028. No abstract available.
- Background: PubMed 34977873Cheng Y, Zhang T, Xu Q. Therapeutic advances in non-small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy. MedComm (2020). 2021 Dec 14;2(4):692-729. doi: 10.1002/mco2.105. eCollection 2021 Dec.
- Background: PubMed 27413711Zappa C, Mousa SA. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016 Jun;5(3):288-300. doi: 10.21037/tlcr.2016.06.07.
- Background: PubMed 24867533Parikh RB, Cronin AM, Kozono DE, Oxnard GR, Mak RH, Jackman DM, Lo PC, Baldini EH, Johnson BE, Chen AB. Definitive primary therapy in patients presenting with oligometastatic non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):880-7. doi: 10.1016/j.ijrobp.2014.04.007. Epub 2014 May 24.
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- 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.
Zhijie Wang study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy and Immunotherapy (with or without chemotherapy) maintenance therapy in people with Non-Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 12 inclusion and 18 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 30 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 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 Zhijie Wang, MD (+8613466323860, jie_969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: The estimated median PFS time from entry into maintenance therapy to recurrence in the control group is 6 months. The experimental group is expected to extend median PFS time from 6 months to 8.7 months.). 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 NCT07014202, which also lists 18 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 30 Jul 2025.