Non Small Cell Lung CancerPhase 2Endouble 2NCT07818304
SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC
A Phase 2 study testing Stereotactic Radiation Therapy, Envafolimab and Endostar in people with Non Small Cell Lung Cancer and Lung Neoplasms, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Neoplasms
- What is being tested?
- Stereotactic Radiation Therapy, Envafolimab and Endostar
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study, sign the written informed consent form, and demonstrate good compliance.
- Aged 18-80 years old at the time of signing informed consent, male or female.
- Histologically confirmed stage IV non-small-cell lung cancer (NSCLC) according to the 8th IASLC/AJCC TNM staging system, with negative actionable driver gene alterations (EGFR/ALK/ROS1), and no prior systemic anti-cancer treatment.
- Provide archived tumor tissue samples or newly obtained core/excisional biopsy specimens from tumor lesions which have not received prior anti-tumor therapy or radiotherapy. Formalin-fixed paraffin-embedded (FFPE) tissue blocks are preferred over slides; newly-obtained biopsy samples are preferred over archived tissues. PD-L1 expression ≥1% is confirmed by immunohistochemistry. For subjects without newly-obtained tissue, 5-8 slices of 3-5 μm paraffin sections of archived tissue collected within 2 years before enrollment are acceptable.
- Have at least one radiologically measurable lesion per RECIST version 1.1: target lesion with longest diameter ≥10 mm on CT/MRI, or pathologically enlarged lymph node with short-axis diameter ≥15 mm on CT scan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Expected survival time ≥ 3 months.
- Treatment-naive patients without previous systemic anti-tumor therapy (including radiotherapy, chemotherapy, targeted or immunotherapy), or patients with disease recurrence more than 6 months after completion of postoperative adjuvant chemotherapy.
- Adequate organ and bone marrow function confirmed by laboratory tests obtained within 7 days before enrollment. No blood product transfusion, growth factors, albumin or other corrective medications are permitted within 14 days prior to laboratory assessment:
- 1) Hematology: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥75×10⁹/L, hemoglobin (HGB) ≥90 g/L (no transfusion or erythropoietin-dependency within 14 days); 2) Liver function: total bilirubin (TBIL) ≤2×ULN; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤5×ULN; serum albumin ≥28 g/L; alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min using Cockcroft-Gault formula; urine protein <2+ on urinalysis. For baseline urine protein ≥2+, 24-hour urine protein quantification must be <1 g.
- 4) Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. For subjects receiving anticoagulants, INR within the therapeutic target range of anticoagulation is acceptable.
- 10. For women of child-bearing potential, negative urine or serum pregnancy test within 3 days prior to first study drug administration.
- 11. Tissue samples must be available for biomarker (e.g. PD-L1) analysis. Newly-obtained specimens are preferred; archived paraffin sections obtained within 2 years before enrollment are allowed if fresh tissue cannot be acquired.
Who cannot join
- Tumor invades major blood vessels on CT/MRI, or judged to carry high risk of invading critical vessels and causing fatal hemorrhage during study treatment.
- Currently participating in another interventional clinical trial, or received investigational drug/device within 4 weeks before first study drug administration.
- Received anti-tumor Chinese patent medicine or immunomodulatory agents (such as thymosin, interferon, interleukin) within 2 weeks prior to first dose; or underwent major surgical operation within 3 weeks before first dose.
- Active hemoptysis requiring clinical intervention, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis.
- Any bleeding diathesis regardless of severity; any bleeding/hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before enrollment; unhealed wound, ulcer or fracture.
- New York Heart Association (NYHA) class III-IV congestive heart failure, or uncontrolled clinically significant arrhythmia.
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- History of arterial thrombosis, embolism or ischemic events within 6 months before study entry, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack.
- Known hypersensitivity to any study drug.
- Require chronic systemic corticosteroid therapy. Intermittent bronchodilators, inhaled corticosteroids for COPD/asthma, or local corticosteroid injection are permitted.
- Symptomatic central nervous system (CNS) metastases. Patients with asymptomatic or treated-stable brain metastases may be enrolled only if all of the following criteria are met: measurable extracranial lesion; no midbrain, pons, cerebellum, meningeal, medulla oblongata or spinal cord metastasis; clinically stable for at least 2 weeks; systemic steroid discontinued at least 3 days before first study drug dose.
- Active infection requiring treatment, or systemic anti-infective medication administered within 1 week before first dose. Subjects have not sufficiently recovered from toxicity/complications induced by prior interventions (≤ grade 1 or return to baseline, excluding fatigue and alopecia).
- Known human immunodeficiency virus (HIV-1/2 antibody positive).
- Untreated active hepatitis B (HBsAg positive with HBV-DNA above local laboratory upper limit of normal). Subjects with HBV viral load <1000 copies/mL (200 IU/mL) are eligible and should receive anti-HBV prophylaxis during study therapy to prevent viral reactivation. Anti-HBc positive, HBsAg negative, anti-HBs negative and HBV-DNA negative subjects do not require prophylactic anti-HBV therapy but need close monitoring for viral reactivation.
- Active hepatitis C infection (HCV-Ab positive with HCV-RNA above assay lower limit).
- Received live-attenuated vaccine within 30 days before Cycle 1 Day 1. Seasonal inactivated injectable influenza vaccine within 30 days before first dose is allowed; intranasal live-attenuated influenza vaccine is prohibited.
- Pregnant or breastfeeding women.
- Medical history, disease condition, treatment or laboratory abnormality that may interfere with study results or prevent full participation in the trial; or other conditions judged by the investigator to render the subject unsuitable for enrollment or associated with potential safety risks.
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
Lianyungang First People's Hospital
Lianyungang
Xiaodong Jiang, 86-18961325359, jxdysy1970@126.com
About this study
Official title: A Prospective, Single-arm Exploratory Clinical Study of SRT Combined With Envafolimab and Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression
This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.
Read the detailed description
This prospective multi-center single-arm phase II trial focuses on unresectable stage IV NSCLC patients with negative driver genes and positive PD-L1 expression (TPS ≥1%). Eligible subjects are treatment-naive patients or recurrent cases after adjuvant chemotherapy. Patients will receive stereotactic body radiation therapy targeting 1 to 5 metastatic lesions with a dose of 30-50 Gy in 5-10 fractions. Within 1 to 7 days after radiotherapy, patients will receive 300 mg envafolimab subcutaneously on day 1 and 210 mg endostar continuous intravenous pumping on days 1-3 of each 3-week cycle. The overall clinical efficacy and safety profiles of this combined regimen will be systematically observed.
- Conditions
- Non Small Cell Lung Cancer, Lung Neoplasms
- Being tested
- Stereotactic Radiation Therapy, Envafolimab, Endostar
- Keywords
- Non-small-cell lung cancer, Stereotactic radiation therapy, Envafolimab, Endostar, Immunotherapy, Anti-angiogenic therapy, Phase II clinical trial
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiation TherapyRadiation
Stereotactic radiotherapy delivered to 1-5 metastatic lesions, with a total dose of 30-50 Gy in 5-10 fractions. Lesions are selected based on larger volume, symptomatic status, or visceral location; treatment of all metastatic lesions is not required.
EnvafolimabDrug
300 mg administered by subcutaneous injection on Day 1 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy.
EndostarDrug
210 mg administered by continuous intravenous pumping on Days 1-3 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| SRT + Envafolimab + Endostar | Experimental | All eligible subjects receive stereotactic body radiotherapy combined with envafolimab and endostar as first-line treatment. Receives: Radiation: Stereotactic Radiation Therapy; Drug: Envafolimab; Drug: Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST version 1.1. CR and PR must be confirmed by subsequent tumor assessment during the study.
Measured: From treatment initiation up to 24 weeks
Incidence of Treatment-Related Adverse Events
Number and severity of treatment-related adverse events, laboratory abnormalities, vital sign and electrocardiogram changes, evaluated according to NCI-CTCAE version 5.0. Safety analyses will be performed in the safety set.
Measured: From first study treatment to 90 days after last study treatment
Secondary outcomes (4)
Progression-Free Survival (PFS)
Time from treatment initiation to first documented radiological disease progression (per RECIST v1.1, investigator-assessed) or death from any cause, whichever occurs first. Participants without progression or death will be censored at the date of last valid tumor assessment.
Measured: From treatment start until progression or death, up to 36 months
Overall Survival (OS)
Time from treatment initiation to death due to any cause.
Measured: From treatment start until death from any cause, up to 48 months
Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.
Measured: From treatment initiation up to 24 weeks
Duration Of Response (DOR)
Time interval from the first documented objective tumor response until disease progression or death from any cause, whichever occurs first.
Measured: From first confirmed response until progression or death, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818304
- Sponsor's protocol ID
- KY-20250711001
- Acronym
- Endouble 2
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Exploratory Clinical Study of SRT Combined With Envafolimab and Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression
- ClinicalTrials.gov ID
- NCT07818304
- Acronym / sponsor ID
- Endouble 2 / KY-20250711001
- Conditions
- Non Small Cell Lung Cancer, Lung Neoplasms
- Keywords
- Non-small-cell lung cancer, Stereotactic radiation therapy, Envafolimab, Endostar, Immunotherapy, Anti-angiogenic therapy, Phase II clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Sep 2026 (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 is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.
Detailed description
This prospective multi-center single-arm phase II trial focuses on unresectable stage IV NSCLC patients with negative driver genes and positive PD-L1 expression (TPS ≥1%). Eligible subjects are treatment-naive patients or recurrent cases after adjuvant chemotherapy. Patients will receive stereotactic body radiation therapy targeting 1 to 5 metastatic lesions with a dose of 30-50 Gy in 5-10 fractions. Within 1 to 7 days after radiotherapy, patients will receive 300 mg envafolimab subcutaneously on day 1 and 210 mg endostar continuous intravenous pumping on days 1-3 of each 3-week cycle. The overall clinical efficacy and safety profiles of this combined regimen will be systematically observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRT + Envafolimab + Endostar | Experimental | Radiation: Stereotactic Radiation Therapy, Drug: Envafolimab, Drug: EndostarAll eligible subjects receive stereotactic body radiotherapy combined with envafolimab and endostar as first-line treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects voluntarily participate in this study, sign the written informed consent form, and demonstrate good compliance.
- Aged 18-80 years old at the time of signing informed consent, male or female.
- Histologically confirmed stage IV non-small-cell lung cancer (NSCLC) according to the 8th IASLC/AJCC TNM staging system, with negative actionable driver gene alterations (EGFR/ALK/ROS1), and no prior systemic anti-cancer treatment.
- Provide archived tumor tissue samples or newly obtained core/excisional biopsy specimens from tumor lesions which have not received prior anti-tumor therapy or radiotherapy. Formalin-fixed paraffin-embedded (FFPE) tissue blocks are preferred over slides; newly-obtained biopsy samples are preferred over archived tissues. PD-L1 expression ≥1% is confirmed by immunohistochemistry. For subjects without newly-obtained tissue, 5-8 slices of 3-5 μm paraffin sections of archived tissue collected within 2 years before enrollment are acceptable.
- Have at least one radiologically measurable lesion per RECIST version 1.1: target lesion with longest diameter ≥10 mm on CT/MRI, or pathologically enlarged lymph node with short-axis diameter ≥15 mm on CT scan.
Key exclusion criteria (17 listed)
- Tumor invades major blood vessels on CT/MRI, or judged to carry high risk of invading critical vessels and causing fatal hemorrhage during study treatment.
- Currently participating in another interventional clinical trial, or received investigational drug/device within 4 weeks before first study drug administration.
- Received anti-tumor Chinese patent medicine or immunomodulatory agents (such as thymosin, interferon, interleukin) within 2 weeks prior to first dose; or underwent major surgical operation within 3 weeks before first dose.
- Active hemoptysis requiring clinical intervention, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis.
- Any bleeding diathesis regardless of severity; any bleeding/hemorrhagic event ≥ CTCAE grade 3 within 4 weeks before enrollment; unhealed wound, ulcer or fracture.
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 |
|---|---|---|
| Stereotactic Radiation TherapyStereotactic radiotherapy delivered to 1-5 metastatic lesions, with a total dose of 30-50 Gy in 5-10 fractions. Lesions are selected based on larger volume, symptomatic status, or visceral location; treatment of all metastatic lesions is not required. | Radiation | SRT + Envafolimab + Endostar |
| Envafolimab300 mg administered by subcutaneous injection on Day 1 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy. | Drug | SRT + Envafolimab + Endostar |
| Endostar210 mg administered by continuous intravenous pumping on Days 1-3 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy. | Drug | SRT + Envafolimab + Endostar |
Primary outcome
Objective Response Rate (ORR)
Time frame: From treatment initiation up to 24 weeks
Percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST version 1.1. CR and PR must be confirmed by subsequent tumor assessment during the study.
Incidence of Treatment-Related Adverse Events
Time frame: From first study treatment to 90 days after last study treatment
Number and severity of treatment-related adverse events, laboratory abnormalities, vital sign and electrocardiogram changes, evaluated according to NCI-CTCAE version 5.0. Safety analyses will be performed in the safety set.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From treatment start until progression or death, up to 36 months
Overall Survival (OS)
Time frame: From treatment start until death from any cause, up to 48 months
Disease Control Rate (DCR)
Time frame: From treatment initiation up to 24 weeks
Duration Of Response (DOR)
Time frame: From first confirmed response until progression or death, up to 36 months
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 14 Sep 2026.
- 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.
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 Stereotactic Radiation Therapy, Envafolimab and Endostar in people with Non Small Cell Lung Cancer and Lung Neoplasms, run by The First People's Hospital of Lianyungang 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 17 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 14 Sep 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 Xiaodong Jiang, MD (86-18961325359, jxdysy1970@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From treatment initiation up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.