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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT06775743

ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs

A Phase 2 study testing ORIENT-31 regimen and SBRT in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR Mutation Positive Advanced Non Small Cell Lung Cancer, run by Fudan University at 1 site 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

The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ORIENT-31 regimen and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
15 Jan 2025to Jun 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

  • ECOG performance status score of 0-1;
  • Histologically or cytologically confirmed stage IV primary non-small cell lung cancer;
  • EGFR-sensitive mutations (L858R, 19del);
  • Resistance to first-line treatment with third-generation EGFR-TKIs;
  • At least one measurable lesion;
  • Patients with brain metastases may be included, but they must be asymptomatic neurologically and have stable lesions without the need for systemic corticosteroid treatment;
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  • Men and women of reproductive age agree to contraception during the trial (surgical sterilization or oral contraceptives/intrauterine device + condoms);
  • Life expectancy ≥ 3 months;
  • Within one week before enrollment, organ function levels must meet the following criteria:
  • Bone marrow function: Hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 × 10^9/L or neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L;
  • Liver: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total bilirubin level > 1.5 times the upper limit of normal, direct bilirubin level must be ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal;
  • Kidney: Serum creatinine level < 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 ml/min, blood urea nitrogen ≤ 200 mg/L; serum albumin ≥ 30 g/L;
  • Patients must have the capacity to understand and voluntarily sign the informed consent form.

Who cannot join

  • Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.
  • Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia.
  • Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.
  • History of other malignant tumors.
  • Patients with active infections, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmias.
  • Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases.
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  • Patients whom the investigator believes currently have lesions requiring palliative radiation therapy.
  • Mixed with small cell lung cancer components.
  • Nursing or pregnant women.
  • Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation.
  • Known hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis infection.
  • Patients who have received cancer vaccines or received other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are often inactivated vaccines and are allowed, while intranasal preparations are usually live attenuated vaccines and are not allowed).
  • Patients who are concurrently using other immunotherapies, chemotherapy drugs, drugs from other clinical trials, or require long-term corticosteroid treatment are not eligible for enrollment.
  • Patients with psychiatric disorders, substance abuse, or social issues that affect compliance are not eligible for enrollment after physician review.
  • Patients who are allergic to or contraindicated for PD-1 monoclonal antibodies, VEGF monoclonal antibodies, or chemotherapy drugs.
  • Withdrawl criteria:
  • Incorrectly enrolled participants. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the investigator should assess the participant's benefit-risk profile and then decide whether to withdraw. If withdrawal is necessary, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.
  • Participants who experience the following during the pre-treatment evaluation phase: new systemic diseases or worsening of existing systemic diseases that meet exclusion criteria; voluntary withdrawal, loss to follow-up, or death; poor compliance.
  • Participants whom the investigator deems necessary to exclude. The investigator must report the reason for exclusion to the principal investigator and obtain consent. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.
  • Participants may request to withdraw from the clinical trial at any time during the trial process.
  • Participants who experience serious adverse events during the trial, and whom the investigator deems should stop participating in the trial.
  • Participants whose condition worsens during the trial, potentially threatening their life, or who develop other conditions that affect trial observations.
  • Participants who are lost to follow-up or die during the treatment phase.
  • Participants who use chemotherapy, traditional Chinese medicine, other immunotherapy drugs, radiotherapy sensitizers, or other agents that affect efficacy and toxicity evaluation during the trial period.
  • Participants in whom serious deviations occur during the implementation of the clinical trial protocol, making it difficult to evaluate the drug's effect; those with poor compliance.
  • Exit criteria:
  • Wrong enrollees who did not meet the inclusion criteria;
  • Serious protocol violations.

Trial locations and contacts

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

Zhengfei Zhu, PhD contact

86-18017312901

fuscczzf@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhengfei Zhu, Dorctor, 86-18017312901, fuscczzf@163.com

    Recruiting

Other trials in China

About this study

Official title: ORIENT-31 Regimen (Sintilimab Plus Bevacizumab Plus Platinum-doublet Chemotherapy) in Combination With Stereotactic Radiotherapy in EGFR-mutant Metastatic Non-small Cell Lung Cancer After First-line Third-generation EGFR Tyrosine Kinase Inhibitors (ORBIT Study)

The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients who failed first-line third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Participants will first receive the standard four-drug combination therapy: PD-1 antibody + vascular endothelial growth factor (VEGF) antibody + platinum + pemetrexed. The efficacy will be evaluated every two courses. According to the efficacy evaluation results, personalized SBRT was be administered.

Being tested
ORIENT-31 regimen, SBRT
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.

  • ORIENT-31 regimenDrug

    Sintilimab plus bevacizumab plus platinum-doublet chemotherapy

  • SBRTRadiation

    Based on the results of the response evaluation, personalized SBRT will be arranged after cycle 4:

    1. Complete response, CR: continue with maintenance therapy of PD-1 antibody + pemetrexed + VEGF antibody until disease progression, intolerable toxic side effects, or up to two years.
    2. Stable disease, SD/partial response, PR: if the residual lesions do not exceed three organs and five lesions, and if the investigator deems SBRT feasible, curative-dose stereotactic radiotherapy covering all residual lesions will be administered, with dosing based on the NRG-BR001 study.
    3. If the residual lesions exceed three organs or five lesions, SBRT (24 Gy/3 Fx) targeting 1-3 selected tumor lesions will be performed, and then continue with maintenance therapy of PD-1 antibody + pemetrexed + VEGF antibody until disease progression.
    4. Progressive disease, PD: subsequent treatment is conducted according to the standard guidelines.
Study groups in NCT06775743
Study groupRoleWhat they receive
SBRT plus ORIENT-31 regimenExperimentalNot described
Receives: Drug: ORIENT-31 regimen; Radiation: SBRT

What is being measured

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

  1. Progression-Free Survival (PFS)

    The time from the start of drug treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.

    Measured: 1 year

Secondary outcomes (3)

  1. Overall Survival (OS)

    The time from the start of drug treatment until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.

    Measured: 1 year

  2. Objective Response Rate (ORR)

    The percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) after treatment, assessed according to the RECIST 1.1 criteria.

    Measured: 1 year

  3. Treatment-related adverse event (TRAE)

    Investigator-assessed treatment-related adverse events were recorded and assessed according to CTCAE5.0.

    Measured: 1 year

Timeline

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

  1. First posted15 Jan 2025
  2. Study start15 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completionJun 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775743
Sponsor's protocol ID
ORBIT
Status last verified
Jan 2026
First submitted
10 Jan 2025
Last updated
11 Mar 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 ORIENT-31 regimen and SBRT in people with NSCLC (Advanced Non-small Cell Lung Cancer) and EGFR Mutation Positive Advanced Non Small Cell Lung Cancer, run by Fudan 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 13 inclusion and 28 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhengfei Zhu, PhD (86-18017312901, fuscczzf@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: 1 year). 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 NCT06775743.

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 11 Mar 2026.

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