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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07418866

FANLUNG-2：The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab and High-Low Mixed-Dose Radiotherapy Group in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University.

Not yet recruiting

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

Official record
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Trial summary

Moving immunotherapy ahead of chemoradiotherapy in a "sandwich" model-where tumor reduction is achieved through induction chemo-immunotherapy, immunotherapy is paused during chemoradiotherapy, and then resumed as maintenance post-radiotherapy-has shown promising potential. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab and High-Low Mixed-Dose Radiotherapy Group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
Feb 2026to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent obtained prior to the initiation of any trial-related procedures.
  • Age > 18 years.
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  • Negative for driver gene mutations (EGFR, ALK, ROS1, RET, MET exon 14 skipping, HER2, BRAF, KRAS G12C).
  • Locally advanced disease, including Stage III and selected Stage IV (where all lesions are deemed safely treatable with a radiotherapy dose > 50 Gy in 10 fractions, as assessed by a senior radiation oncologist).
  • At least one thoracic lesion with a short-axis diameter > 2 cm.
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  • Positive hilar or mediastinal lymph nodes.
  • ECOG Performance Status of 0 or 1.
  • Life expectancy > 3 months.
  • Adequate organ function, as defined by the following laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.
  • Platelet count ≥ 100 × 10⁹/L.
  • Hemoglobin > 9 g/dL.
  • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
  • Serum creatinine ≤ 1.5 × ULN AND calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL/min.
  • Adequate coagulation, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN.
  • Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within normal limits. Subjects with baseline TSH outside the normal range may be enrolled if both total T3 (or free T3) and free T4 levels are within normal limits.
  • Cardiac enzymes within normal limits (subjects may be enrolled if the investigator judges isolated laboratory abnormalities to be clinically insignificant).
  • For female subjects of childbearing potential, a negative urine or serum pregnancy test must be documented within 3 days prior to receiving the first dose of study medication (Cycle 1, Day 1). If a urine pregnancy test result is ambiguous or cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as being postmenopausal for at least 1 year, surgically sterile, or having undergone a hysterectomy.
  • Subjects (both male and female) at risk of pregnancy must agree to use highly effective contraception (with a failure rate of <1% per year) throughout the treatment period and for 120 days after the last dose of study medication (or 180 days after the last dose of chemotherapy), whichever is later.

Who cannot join

  • Patients with severe emphysema, interstitial lung changes, or COPD;
  • Resting blood oxygen saturation < 93%;
  • History of other malignancies requiring chemotherapy within the past 2 years;
  • History of thoracic radiotherapy;
  • Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment;
  • Current use of systemic corticosteroids (>10 mg daily prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first study dose (excluding topical, nasal, inhaled, or local corticosteroids); *Note: Physiological corticosteroid doses (≤10 mg/day prednisone or equivalent) are permitted.*
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  • Known history of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation;
  • Known allergy to any component of the study drug or its excipients;
  • Known history of HIV infection (positive HIV1/2 antibodies);
  • Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA above the upper limit of normal at the local laboratory);
  • Note: Hepatitis B subjects meeting the following criteria may be enrolled:
  • HBV DNA < 1000 copies/mL (200 IU/mL) before the first dose, with ongoing antiviral therapy throughout chemotherapy to prevent reactivation; b) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV DNA (-) do not require prophylactic antiviral therapy but require close monitoring for reactivation.
  • Active HCV infection (positive HCV antibody with detectable HCV-RNA above the lower limit of detection);
  • Administration of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated seasonal influenza vaccines are permitted within 30 days prior to the first dose; live attenuated intranasal influenza vaccines are not allowed.
  • Pregnant or breastfeeding women;
  • Any severe or uncontrolled systemic disease, including but not limited to:
  • Resting ECG showing clinically significant uncontrolled abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation);
  • Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Class ≥2;
  • Arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, stroke, or transient ischemic attack);
  • Poorly controlled hypertension (systolic BP >140 mmHg or diastolic BP >90 mmHg);
  • History of non-infectious pneumonitis requiring corticosteroids within 1 year prior to the first dose, or current clinically active interstitial lung disease;
  • Active tuberculosis;
  • Active or uncontrolled infection requiring systemic therapy;
  • Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
  • Poorly controlled diabetes (fasting blood glucose >10 mmol/L);
  • Urine dipstick showing protein ≥++ with confirmed 24-hour urine protein >1.0 g;
  • Psychiatric disorders that may interfere with treatment compliance;
  • Any other condition (e.g., medical history, disease, ongoing treatment, or laboratory abnormality) that may interfere with study results, compromise patient participation, or pose additional risks-in the investigator's judgment-making the subject unsuitable for study enrollment.

About this study

Official title: The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer - A Prospective, Open-Label, Randomized Controlled, Phase II Study (FANLUNG-2)

Moving immunotherapy ahead of chemoradiotherapy in a "sandwich" model-where tumor reduction is achieved through induction chemo-immunotherapy, immunotherapy is paused during chemoradiotherapy, and then resumed as maintenance post-radiotherapy-has shown promising potential. However, this approach still faces two main challenges: insufficient depth of tumor response and an increased risk of radiation pneumonitis.To address these issues, we investigators have designed a novel high-low mixed-dose irradiation strategy. This approach, combined with two cycles of induction chemo-immunotherapy, aims to achieve rapid tumor regression, improve disease control rates, and reduce overall lung radiation exposure.

Being tested
Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab, High-Low Mixed-Dose Radiotherapy Group
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.

  • Paclitaxel Micelles ; Cisplatin ; 5-FU ; SerplulimabDrug

    Paclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m² ; 5-FU 1200 mg/m²; Serplulimab 200 mg

  • High-Low Mixed-Dose Radiotherapy GroupRadiation

    A high-low mixed-dose irradiation approach: for large lesions (short diameter > 2 cm), central ablative radiotherapy is applied, delivering a single ablative dose of 15-20 Gy to approximately one-quart

Study groups in NCT07418866
Study groupRoleWhat they receive
Chemo-immunotherapy + High-Low Mixed-Dose Radiotherapy GroupExperimentalTwo cycles of chemo-immunotherapy (Paclitaxel Micelles 100 mg/m²; Cisplatin 30 mg/m²; 5-FU 1200 mg/m²; Serplulimab 200 mg); central ablative radiotherapy: for large masses (short diameter > 2 cm), the central 1/4 region receives 15-20 Gy/1 fraction, with the 5 Gy isodose line not exceeding the GTV, and maximum doses to the esophagus, trachea, and spinal cord kept below 3 Gy; low-dose radiotherapy: for small masses (short diameter < 2 cm), 2 Gy/1 fraction. Efficacy evaluation is performed before the third chemotherapy cycle, along with radiotherapy simulation. The fourth chemotherapy cycle is administered concurrently during radiotherapy. Immunotherapy is initiated 1-42 days after radiotherapy completion and maintained for 2 years.
Receives: Drug: Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab; Radiation: High-Low Mixed-Dose Radiotherapy Group
Chemo-immunotherapy GroupActive comparator2 cycles of chemoradiotherapy (Paclitaxel (micellar) 100 mg/m²; Cisplatin 30 mg/m²; 5-Fluorouracil 1200 mg/m²; Serplulimab 200 mg). Efficacy evaluation will be conducted prior to the 3rd chemotherapy cycle, along with radiotherapy simulation. The 4th chemotherapy cycle will be administered concurrently with radiotherapy. Immunotherapy maintenance will begin within 42 days after completion of radiotherapy and continue for 2 years.
Receives: Drug: Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab

What is being measured

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

  1. Objective Response Rate

    Measured: At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days)

Secondary outcomes (3)

  1. Tumor Volume Reduction Rate

    Measured: At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days)

  2. PET-CT Negative Conversion Rate

    Measured: At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days)

  3. The incidence of ≥ Grade 2 radiation pneumonitis

    Measured: one year

Timeline

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

  1. First posted18 Feb 2026
  2. Study startFeb 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07418866
Sponsor's protocol ID
2503317-8
Status last verified
Feb 2026
First submitted
12 Jan 2026
Last updated
18 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel Micelles ; Cisplatin ; 5-FU ; Serplulimab and High-Low Mixed-Dose Radiotherapy Group in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University.

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 21 inclusion and 29 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: At the end of Cycle 2 chemo- immune therapy (each cycle is 21 days)). 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 NCT07418866.

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 18 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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