EGFR Mutation Positive Advanced Non Small Cell Lung CancerPhase 2LIBRANCT06982924
A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.
A Phase 2 study testing Limertinib+bevacizumab and Limertinib in people with EGFR Mutation Positive Advanced Non Small Cell Lung Cancer and PD-L1 Positive, run by Shanghai Chest Hospital.
Trial summary
A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutation Positive Advanced Non Small Cell Lung Cancer, PD-L1 Positive
- What is being tested?
- Limertinib+bevacizumab and Limertinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 30 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 prior to any study - related procedures.
- Age ≥ 18 years.
- Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC).
- Patients with locally advanced (IIIB - IIIC), metastatic, or recurrent (Stage IV) disease, as staged according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer (AJCC) 9th edition TNM staging for lung cancer, who are not candidates for surgical or radiation therapy.
- Confirmed EGFR - sensitive mutations (Ex19del, L858R) in tumor histology or cytology or in hematology.
- PD - L1 expression with a Combined Positive Score (CPS) ≥ 25%.
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- ECOG performance status score of 0 - 1.
- No prior treatment with anti - angiogenic inhibitors or EGFR - TKIs.
- At least one radiologically measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions within a previously irradiated field may be considered measurable if progression has been confirmed.
- Asymptomatic or symptomatic - stable brain metastases after local treatment are allowed, provided that the following conditions are met: - Measurable disease outside the central nervous system (CNS). - No CNS symptoms or worsening of symptoms within the past 2 weeks. - No need for glucocorticoid treatment, or glucocorticoid treatment discontinued within 7 days prior to the first dose, or stable and reduced glucocorticoid dose to ≤ 10 mg/day prednisone (or equivalent) within 7 days prior to the first dose.
- Expected survival time > 3 months.
- Adequate organ function, with the following laboratory values met by subjects: - Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without the use of granulocyte - colony stimulating factor (G - CSF) within the past 14 days. - Platelets ≥ 100×10⁹/L without blood transfusion within the past 14 days. - Hemoglobin > 9 g/dL without blood transfusion or use of erythropoiesis - stimulating agents within the past 14 days. - Total bilirubin ≤ 1.5× the upper limit of normal (ULN). - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (for subjects with liver metastases, ALT or AST ≤ 5×ULN is allowed). - Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft - Gault formula) ≥ 60 ml/min. - Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN. - Normal thyroid function, defined as thyroid - stimulating hormone (TSH) within the normal range. Subjects may also be included if their baseline TSH is outside the normal range but their total T3 (or free T3) and free T4 are within the normal range. - Cardiac enzyme profile within the normal range (isolated laboratory abnormalities deemed not clinically significant by the investigator are also allowed).
- For women of childbearing age, a negative urine or serum pregnancy test must be conducted within 3 days prior to the first dose of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a blood pregnancy test is required. Non - childbearing - age women are defined as those who have been post - menopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy.
- All subjects (regardless of gender) with the potential for conception must use contraceptive measures with a failure rate of less than 1% throughout the entire treatment period and until 120 days (or 180 days) after the last dose of the study drug.
Who cannot join
- Pathologically diagnosed with small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and NSCLC.
- Patients who have received any EGFR - TKI treatment or anti - angiogenic therapy.
- Received the following treatments: - Systemic anti - tumor treatment such as chemotherapy, targeted therapy, or immunotherapy (including traditional Chinese medicine for anti - tumor purposes) within 3 weeks prior to treatment. - Any investigational drug treatment within 4 weeks prior to treatment. - High - dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day prednisone or equivalent doses) within 4 weeks prior to treatment. - Attenuated live vaccines within 4 weeks prior to treatment (or planned to receive attenuated live vaccines during the study period). - Major surgery (such as open - cavity, open - chest, or laparotomy) within 4 weeks prior to treatment, or unresolved surgical wounds, ulcers, or fractures.
- Clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not require drainage of effusion or whose effusion does not significantly increase after stopping drainage for 3 days are eligible for inclusion).
- Subjects who received chest radiotherapy with a dose greater than 30Gy within 6 months prior to treatment, or palliative radiotherapy with a dose of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is allowed).
- Active autoimmune diseases that required systemic treatment (such as disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of study drug. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
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- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to the active ingredients or excipients of the study drugs bevacizumab and lerotinib.
- Not fully recovered from the toxicity and/or complications caused by any intervention prior to the start of treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or hair loss).
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies).
- Untreated active hepatitis B (defined as positive for HBsAg and HBV - DNA copies greater than the upper limit of normal in the laboratory of the research center). Note: Subjects with hepatitis B who meet the following criteria are also eligible for inclusion: - HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose of study drug, and subjects should receive anti - HBV treatment throughout the study drug treatment period to prevent viral reactivation. - For subjects with positive anti - HBc, negative HBsAg, negative anti - HBs, and negative HBV viral load, preventive anti - HBV treatment is not required, but close monitoring for viral reactivation is necessary.
- Subjects with active HCV infection (positive for HCV antibodies and HCV - RNA levels above the lower limit of detection).
- Received live vaccines within 30 days prior to the first dose of study drug (Day 1 of Cycle 1). Note: It is allowed to receive injectable inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose of study drug 2: however, intranasal attenuated live influenza vaccines are not allowed. 14. Pregnant or lactating women.
- 15. Any severe or uncontrolled systemic disease, such as: - Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram that are difficult to control, such as complete left bundle branch block, second - degree or higher cardiac conduction block, ventricular arrhythmias, or atrial fibrillation. - Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) classification of ≥ Grade 2. - Myocardial infarction within 6 months prior to enrollment. - Poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). - History of non - infectious pneumonia that required glucocorticoid treatment within 1 year prior to the first dose of study drug, or current clinically active interstitial lung disease. - Active pulmonary tuberculosis. - Active or uncontrolled infections that require systemic treatment. - Clinically active diverticulitis, intra - abdominal abscess, or gastrointestinal obstruction. - Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. - Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L). - Urine routine test indicating proteinuria ≥ ++, and confirmed 24 - hour urine protein quantification > 1.0 g. - Subjects with mental disorders who are unable to cooperate with treatment.
- 16. Any medical history or evidence of disease, treatment, or laboratory test abnormalities that may interfere with the study results or prevent the subject from fully participating in the study, or other situations deemed by the investigator as unsuitable for inclusion. The investigator considers there are other potential risks that make the subject unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.
A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.
- Being tested
- Limertinib+bevacizumab, Limertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limertinib+bevacizumabDrug
Also called ASK120067
The advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive the combination of Limertinib with bevacizuma in first-line treatment
LimertinibDrug
The advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive Limertinib in first-line treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Limertinib+bevacizumab |
| Control Group | Placebo comparator | Not described Receives: Drug: Limertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the investigator assessed PFS
Measured: About 2 years
Secondary outcomes (2)
ORR
the investigator assessed objective response rate
Measured: about 6 month
OS
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Principal investigator, Zhong Runbo, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982924
- Sponsor's protocol ID
- MR-31-25-032614
- Acronym
- LIBRA
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.
- ClinicalTrials.gov ID
- NCT06982924
- Acronym / sponsor ID
- LIBRA / MR-31-25-032614
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 21 May 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.
A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Limertinib+bevacizumab |
| Control Group | Placebo comparator | Drug: Limertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent prior to any study - related procedures.
- Age ≥ 18 years.
- Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC).
- Patients with locally advanced (IIIB - IIIC), metastatic, or recurrent (Stage IV) disease, as staged according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer (AJCC) 9th edition TNM staging for lung cancer, who are not candidates for surgical or radiation therapy.
- Confirmed EGFR - sensitive mutations (Ex19del, L858R) in tumor histology or cytology or in hematology.
Key exclusion criteria (15 listed)
- Pathologically diagnosed with small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and NSCLC.
- Patients who have received any EGFR - TKI treatment or anti - angiogenic therapy.
- Received the following treatments: - Systemic anti - tumor treatment such as chemotherapy, targeted therapy, or immunotherapy (including traditional Chinese medicine for anti - tumor purposes) within 3 weeks prior to treatment. - Any investigational drug treatment within 4 weeks prior to treatment. - High - dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day prednisone or equivalent doses) within 4 weeks prior to treatment. - Attenuated live vaccines within 4 weeks prior to treatment (or planned to receive attenuated live vaccines during the study period). - Major surgery (such as open - cavity, open - chest, or laparotomy) within 4 weeks prior to treatment, or unresolved surgical wounds, ulcers, or fractures.
- Clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not require drainage of effusion or whose effusion does not significantly increase after stopping drainage for 3 days are eligible for inclusion).
- Subjects who received chest radiotherapy with a dose greater than 30Gy within 6 months prior to treatment, or palliative radiotherapy with a dose of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is allowed).
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 |
|---|---|---|
| Limertinib+bevacizumabAlso: ASK120067The advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive the combination of Limertinib with bevacizuma in first-line treatment | Drug | Experimental group |
| LimertinibThe advanced or metastatic non-small cell lung cancer patients with EGFR mutation and high PD-L1 expression will receive Limertinib in first-line treatment | Drug | Control Group |
Primary outcome
PFS
Time frame: About 2 years
the investigator assessed PFS
2 secondary outcomes
ORR
Time frame: about 6 month
OS
Time frame: About 2 years
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 21 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Limertinib+bevacizumab and Limertinib in people with EGFR Mutation Positive Advanced Non Small Cell Lung Cancer and PD-L1 Positive, run by Shanghai Chest Hospital.
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 14 inclusion and 15 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 21 May 2025. 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. Some participants in this study may receive a placebo. 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 Zhong Runbo, MD (+86 021-62821990, zhongrb@shchest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: About 2 years). 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 21 May 2025.