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Solid TumorPhase 1NMNNCT06966583

NAD+ Supplement（NMN）With Radioimmunotherapy in Advanced NSCLC

A Phase 1 study testing NAD supplement, Radiotherapy and Immunotherapy in people with Solid Tumor and Non Small Cell Lung Cancer, run by Sichuan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase I, single center (West China Hospital, Sichuan University) study aimed at investigating the safety and efficacy of NMN supplements combined with chemotherapy and radiation therapy for second-line and above treatment of advanced NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Non Small Cell Lung Cancer
What is being tested?
NAD supplement, Radiotherapy and Immunotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 May 2025to 30 Nov 2027
Phase
Phase 1
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

  • According to the 8th edition TNM staging of lung cancer by the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification in the United States, metastatic (stage IV) non-small cell lung cancer with histological or cytological evidence that cannot be treated surgically and cannot receive curative concurrent chemoradiotherapy, and has received at least first-line treatment.
  • At least 2 measurable target lesions (RECIST v1.1 standard), intracranial lesions are not included as radiation therapy lesions or observation lesions due to immune exemption, liver lesions are not included as observation lesions due to immune exemption, and bone lesions are not included as observation lesions due to non measurability. For a lesion that has previously received radiotherapy, only when there is clear disease progression after radiotherapy can it be considered a target lesion. The patient plans to undergo radiotherapy combined with PD-1 inhibitors, or is currently receiving PD-1 inhibitor treatment and has undergone or plans to undergo radiotherapy within one month from the date of enrollment.
  • Agree to provide tumor tissue specimens, which can be previously archived or freshly obtained, for the detection of biomarkers.
  • Voluntarily sign a written informed consent form. The informed consent form must be signed before any protocol related procedures (which are not part of the subject's routine medical care) are carried out. The subject signs the informed consent form and signs the date. Participants must be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study. At the time of signing the informed consent form, both males and females are eligible for age between 18 and 75 years old.
  • The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1, with an expected survival period of ≥ 3 months.
  • Can provide confirmation of EGFR through tissue based testing, ALK and ROS1 are both reported as wild-type. For non squamous NSCLC patients who have not been confirmed to have wild-type EGFR and wild-type ALK, tumor samples (archived or fresh, primary or metastatic) need to be collected before enrollment for evaluation of EGFR and ALK testing (in local or central laboratories). If there is no archived tumor tissue, fresh tumor biopsy samples must be collected at baseline.
  • The laboratory test results during the screening period indicate that the subjects have good organ function (no blood components or cell growth factors are allowed to support treatment within the first 2 weeks of randomization): Hematology: i. Absolute neutrophil NEC ≥ 1.5 × 10 ^ 9/L; Ii. Platelet count ≥ 100 × 10 ^ 9/L; Iii. Hemoglobin ≥ 9.0g/dL. B Kidney: i. If the calculated creatinine clearance rate (CrCl) is ≥ 50 mL/min, the Cockcroft Gault formula will be used to calculate CrCl (Cockcroft DW, 1976) CrCL (mL/min)={(140 age) × body weight (kg) × F}/(SCr (mg/dL) × 72), where F=1 for females and F=0.85 for males; SCr=serum creatinine. Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; For subjects with liver metastasis or confirmed/suspected Gilbert disease, TBil ≤ 3 × ULN ii AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN d coagulation function: i. International standardized ratio and activated partial thromboplastin time ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT, INR, and APTT) are within the expected range of anticoagulant therapy at screening).

Who cannot join

  • Pregnant or lactating women.
  • Researchers believe that any condition that may pose a risk to receiving study treatment or interfere with the evaluation of study treatment, subject safety, or interpretation of study results.
  • Previously received treatment with EGFR antagonists or ALK antagonists.
  • Previously participated in experimental drug studies or received research treatment or used experimental devices within 4 weeks prior to the first administration.
  • Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or an interventional study with a follow-up period (defined as the time from the first administration to the last administration of the previous clinical study being more than 4 weeks or the study drug having more than 5 half lives).
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
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  • Suffering from active, known or suspected autoimmune diseases, or having a history of autoimmune diseases, except for vitiligo, hair loss, Graves' disease, psoriasis or eczema that do not require systemic treatment within the past 2 years, hypothyroidism (caused by autoimmune thyroiditis) that only requires stable doses of hormone replacement therapy, and type I that only requires stable doses of insulin replacement therapy, diabetes or childhood asthma that have completely alleviated without any intervention after adulthood, or whose disease will not recur without external triggers.
  • Active or previously recorded inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Subjects who require systemic treatment with corticosteroids (>10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to the first administration. Except for the following: a) If there is no active autoimmune disease, inhaled, ophthalmic, or topical corticosteroids and corticosteroids at doses not exceeding 10mg/day effective dose of prednisone are allowed for treatment. b) The dosage of systemic corticosteroids at physiological doses does not exceed 10 mg/day of prednisone or equivalent doses of other corticosteroids. c) Corticosteroids are used as preventive medication for hypersensitivity reactions (such as medication before CT examination).
  • Known history of primary immunodeficiency virus infection.
  • Suffering from other active malignant tumors within the first 5 years of enrollment. Locally curable cancers (manifested as cured) are excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
  • Having undergone major surgical procedures (defined by the investigator, such as open biopsy, severe trauma, etc.) within 28 days prior to the first administration. Note: For the replacement of intravenous drip tubes, it is acceptable. Within 30 days after the first administration (as determined by the researcher), there are significant surgical plans or complete recovery from previous surgeries. Local surgeries (such as placement of systemic ports, hollow core needle biopsy, and prostate biopsy) are allowed, provided that the surgery is completed at least 24 hours before the first administration of the investigational therapeutic drug.
  • Subjects who have not recovered from the toxicity and/or complications of previous interventions to NCI-CTC AE ≤ 1 degree (excluding hair loss and fatigue) prior to their first medication.
  • History of gastrointestinal perforation and/or fistula within 6 months prior to initial administration.
  • Known history of interstitial lung disease. Exclude subjects highly suspected of having interstitial pneumonia; Or subjects who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; Or other moderate to severe lung diseases that seriously affect lung function.
  • Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs.
  • Severe infection occurred within 4 weeks prior to the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
  • Active infections that require systemic treatment.
  • Untreated chronic hepatitis B patients or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or active hepatitis C patients should be excluded. Non active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA<500 IU/mL), and cured hepatitis C patients can be enrolled. For HCV antibody positive subjects, they are only eligible to participate in the study if their HCV RNA test results are negative.
  • Individuals who test positive for HIV.
  • Any of the following cardiovascular diseases: a) Evidence of acute or sustained myocardial ischemia; b) Current symptomatic pulmonary embolism; c) Acute myocardial infarction within the first 6 months of randomization; d) Symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association functional classification) within the first 6 months of randomization; e) Grade 2 or above ventricular arrhythmia within the first 6 months of randomization; f) Cerebrovascular accident (CVA) or transient ischemic attack within the first 6 months of randomization.
  • Those who have received a live or attenuated vaccine within 30 days prior to the first dose, or those who plan to receive the vaccine during the study period.
  • Known history of severe hypersensitivity reactions to other monoclonal antibodies.

Trial locations and contacts

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

Xuanwei Zhang, doctoral contact

18829573328 ext. +86

18609274107@163.com

You Lu, doctoral contact

18829573328 ext. +86

radyoulu@163.com

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Xuanwei Zhang, MD, 18829573328 ext. +86, 18609274107@163.com

    Li Li, MA, 028-85424619 ext. +86, tracy.li_2010@hotmail.com

Other trials in China

About this study

Official title: Safety and Preliminary Efficacy Study of NAD+Supplements (NMN) Combined With Radioimmunotherapy in Advanced Non Small Cell Lung Cancer Patients

This is a phase I, single center (West China Hospital, Sichuan University) study aimed at investigating the safety and efficacy of NMN supplements combined with chemotherapy and radiation therapy for second-line and above treatment of advanced NSCLC.

Read the detailed description

This study is a prospective, phase I, dose exploration (NMN dose escalation) clinical trial of radiotherapy combined with immunotherapy for advanced non-small cell carcinoma. The aim is to evaluate the safety and efficacy of NAD supplementation combined with radiotherapy and immunotherapy (+/- chemotherapy) in 20 patients with advanced non-small cell carcinoma who failed first-line treatment.The patient received PD-1 inhibitor combined with radiation therapy for the primary lesion and/or metastatic site (excluding intracranial lesions), and orally took NAD+supplement NMN. Regular monitoring indicators include ORR and PFS of patients' radiation therapy lesions and other observed lesions, medication safety, biomarkers, and OS.

Tolerance observation will be conducted using a 3+3 NMN dose escalation approach until dose limiting toxicity (DLT) is observed in at least 2 out of 3-6 subjects, or tolerance observation of the study treatment will be conducted。 3 cohorts with increasing dose levels:NMN12000 GeneHarbor:150mg,Oral administration, once a day;Second dose group: NMN12000 GeneHarbor:150mg,Oral administration, twice a day;Third dose group: NMN12000 GeneHarbor:150mg,Oral administration,3 times a day.

Being tested
NAD supplement, Radiotherapy, Immunotherapy
Keywords
Radiotherapy, Stereotactic Ablative Radiotherapy, Immunotherapy, NMN
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.

  • NAD supplementDietary supplement

    Also called NMN

    NAD supplement NMN：NMN12000 GeneHarbor

  • RadiotherapyRadiation

    Low Dose Radiotherapy or Stereotactic Ablative Radiotherapy or Conventional Radiotherapy

  • ImmunotherapyDrug

    Also called PD-1 inhibitor

    PD-1 inhibitor

Study groups in NCT06966583
Study groupRoleWhat they receive
NAD supplement NMN+PD-1 inhibitor+radiotherapyExperimentalThis is a dose escalation study that involves administering radiation therapy (RT) doses, PD-1 inhibitors, and NAD supplements
Receives: Dietary Supplement: NAD supplement; Radiation: Radiotherapy; Drug: Immunotherapy

What is being measured

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

  1. Number of Participants With Adverse Events and/or Dose Limiting Toxicities of NMN supplements in RT+ICI treatment

    Adverse Events and/or Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: from enrollment through 30 days after last dosing, up to 24 months

Secondary outcomes (3)

  1. Progression Free Survival (PFS)

    Investigator assessed PFS according to RECIST v1.1. Progression free survival is defined as time of enrollment to first evidence of progressive disease.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: up to 24 months after the enrollment

  2. Objective Response Rate (ORR)

    Investigator assessed ORR using RECIST v1.1 including the all tumor, the tumor undergoing RT and the tumor which do not receive radiotherapy.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: up to 24 months after the enrollment

  3. Overall Survival (OS)

    OS is defined as the difference (in months) between the date of study enrollment to the date death due to any cause

    Measured: up to 24 months after the enrollment

Timeline

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

  1. First posted12 May 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Nov 2027 (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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966583
Sponsor's protocol ID
HX257253
Other IDs
257253
Acronym
NMN
Status last verified
May 2025
First submitted
2 Apr 2025
Last updated
12 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: data protection until published

Publications

  • Wang Y, Wang F, Wang L, Qiu S, Yao Y, Yan C, Xiong X, Chen X, Ji Q, Cao J, Gao G, Li D, Zhang L, Guo Z, Wang R, Wang H, Fan G. NAD+ supplement potentiates tumor-killing function by rescuing defective TUB-mediated NAMPT transcription in tumor-infiltrated T cells. Cell Rep. 2021 Aug 10;36(6):109516. doi: 10.1016/j.celrep.2021.109516.

    PubMed 34380043

  • Song Q, Zhou X, Xu K, Liu S, Zhu X, Yang J. The Safety and Antiaging Effects of Nicotinamide Mononucleotide in Human Clinical Trials: an Update. Adv Nutr. 2023 Nov;14(6):1416-1435. doi: 10.1016/j.advnut.2023.08.008. Epub 2023 Aug 22.

    PubMed 37619764

  • Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986 Dec;8(6):1245-55. doi: 10.1016/s0735-1097(86)80293-5.

    PubMed 3782631

  • Lv H, Lv G, Chen C, Zong Q, Jiang G, Ye D, Cui X, He Y, Xiang W, Han Q, Tang L, Yang W, Wang H. NAD+ Metabolism Maintains Inducible PD-L1 Expression to Drive Tumor Immune Evasion. Cell Metab. 2021 Jan 5;33(1):110-127.e5. doi: 10.1016/j.cmet.2020.10.021. Epub 2020 Nov 9.

    PubMed 33171124

  • Wu S, Zhang R. CD38-expressing macrophages drive age-related NAD+ decline. Nat Metab. 2020 Nov;2(11):1186-1187. doi: 10.1038/s42255-020-00292-5. No abstract available.

    PubMed 33199923

  • Zhang X, Niedermann G. Abscopal Effects With Hypofractionated Schedules Extending Into the Effector Phase of the Tumor-Specific T-Cell Response. Int J Radiat Oncol Biol Phys. 2018 May 1;101(1):63-73. doi: 10.1016/j.ijrobp.2018.01.094. Epub 2018 Feb 3.

    PubMed 29534901

  • Yin 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

  • Park SS, Dong H, Liu X, Harrington SM, Krco CJ, Grams MP, Mansfield AS, Furutani KM, Olivier KR, Kwon ED. PD-1 Restrains Radiotherapy-Induced Abscopal Effect. Cancer Immunol Res. 2015 Jun;3(6):610-9. doi: 10.1158/2326-6066.CIR-14-0138. Epub 2015 Feb 19.

    PubMed 25701325

  • Deng L, Liang H, Burnette B, Beckett M, Darga T, Weichselbaum RR, Fu YX. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice. J Clin Invest. 2014 Feb;124(2):687-95. doi: 10.1172/JCI67313. Epub 2014 Jan 2.

    PubMed 24382348

  • Kaur P, Asea A. Radiation-induced effects and the immune system in cancer. Front Oncol. 2012 Dec 17;2:191. doi: 10.3389/fonc.2012.00191. eCollection 2012.

    PubMed 23251903

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NAD supplement, Radiotherapy and Immunotherapy in people with Solid Tumor 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 7 inclusion and 23 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: opening soon, as of the sponsor's last update on 12 May 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xuanwei Zhang, doctoral (18829573328 ext. +86, 18609274107@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events and/or Dose Limiting Toxicities of NMN supplements in RT+ICI treatment (time frame: from enrollment through 30 days after last dosing, up to 24 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 NCT06966583, which also lists 10 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 12 May 2025.

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