ALKNCT07870733
Neoadjuvant Iruplinalkib and Bevacizumab in ALK-positive NSCLC: A Phase II Single-arm Trial
A study testing Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC: in people with ALK and NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg/kg, IV, D1). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ALK, NSCLC, Neoadjuvant Therapy
- What is being tested?
- Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Jul 2031
- Phase
- Interventional
- 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
- Signed informed consent.
- Age 18-80 years, both sexes.
- Histologically or cytologically confirmed NSCLC.
- Stage II-III NSCLC per investigator, and ALK-positive.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status 0-1.
Show all 13Show fewer
- Adequate organ and bone marrow function (within 7 days before first dose, no transfusion or growth factor support within 14 days):
- Hb ≥90 g/L, ANC ≥1.5×10⁹/L, PLT ≥90×10⁹/L;
- Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT/AST ≤3.0×ULN (or ≤5.0×ULN if liver metastases), ALB ≥25 g/L;
- INR ≤1.5×ULN, PT/APTT ≤1.5×ULN (or within therapeutic range for anticoagulated patients).
- FEV₁ >60% predicted.
- Women of childbearing potential: negative pregnancy test (serum/urine) within 7 days before enrollment and use of reliable contraception from screening to 3 months after last study drug. Men: adequate contraception or surgically sterile.
- Expected survival ≥12 weeks.
Who cannot join
- Hypersensitivity to iruplinalkib, bevacizumab, or any excipients.
- Prior targeted therapy (TKI or mAb), immunotherapy, or investigational drugs for NSCLC.
- Mixed small-cell and non-small-cell histology.
- Other malignancy within 5 years, except cured basal cell carcinoma, early GI cancer (endoscopically resected), cervical CIS, DCIS, papillary thyroid cancer, or other cured cancers deemed not to affect survival.
- Unstable systemic disease: active infection, uncontrolled hypertension (>160/110 mmHg), unstable angina or angina within 3 months, CHF (NYHA ≥II), MI within 6 months, clinically significant arrhythmia requiring treatment, or QTc >480 ms (average of 3 consecutive measurements if prolonged).
- History of extensive diffuse interstitial lung disease or grade 3/4 pulmonary fibrosis/ILD (excluding localized radiation pneumonitis).
Show all 17Show fewer
- Congenital or acquired immunodeficiency (e.g., HIV).
- Major surgery within 4 weeks before study treatment, or planned major surgery during study.
- Inability to swallow tablets or malabsorption affecting GI absorption.
- Known risk of GI perforation or intestinal obstruction.
- Pregnant or lactating women.
- Any other condition (e.g., alcohol/drug abuse, serious concomitant disease including psychiatric, severe laboratory abnormalities, or social factors) that, in the investigator's opinion, could interfere with study conduct or patient safety.
- History of abdominal fistula, GI perforation, intra-abdominal abscess, or thrombotic disease within 6 months, or judged intolerant to bevacizumab.
- Evidence of hereditary bleeding diathesis or coagulopathy.
- Minor surgery (e.g., catheter placement) within 48 hours before first bevacizumab infusion.
- Imaging evidence of tumor invasion of major vessels (e.g., pulmonary artery or SVC) with bleeding risk per investigator.
- Other factors making the patient unsuitable for the study per investigator.
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 Single-arm, Phase II Clinical Study of Iruplinalkib Combined With Bevacizumab as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer.
This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg/kg, IV, D1). Surgery is performed 4 weeks later, followed by adjuvant iruplinalkib monotherapy for up to 2 years. Primary endpoint is major pathological response (MPR) rate; secondary endpoints include safety, R0 resection rate, and survival outcomes.
- Conditions
- ALK, NSCLC, Neoadjuvant Therapy
- Being tested
- Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:Drug
Eligible patients receive 4 cycles (Q3W) of bevacizumab (15 mg/kg IV on D1) plus iruplinalkib (60 mg oral lead-in for 7 days, then 180 mg daily). Surgery is performed 4 weeks after neoadjuvant therapy, followed by adjuvant iruplinalkib monotherapy for up to 2 years (starting within 4-8 weeks post-surgery), continued until progression, unacceptable toxicity, or loss of benefit.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab combined with iruplinalkib | Experimental | The neoadjuvant treatment phase consists of 4 cycles (Q3W) of bevacizumab (15 mg/kg, intravenous infusion on day 1 of each cycle) combined with iruplinalkib (oral, with a 7-day lead-in of 60 mg once daily, then escalated to 180 mg once daily if tolerated). Surgery is performed 4 weeks after completion of neoadjuvant therapy, and adjuvant maintenance therapy with iruplinalkib monotherapy (180 mg once daily, for up to 2 years) is initiated within 4-8 weeks post-surgery. Discontinuation criteria include disease progression, unacceptable toxicity, or loss of clinical benefit. Receives: Drug: Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
The proportion of subjects undergoing lung cancer resection who have no residual viable tumor cells in both the postoperative tumor bed and lymph nodes.
Measured: up to 30 months
Secondary outcomes (1)
Progression-free survival (PFS)
Time from enrollment to tumor progression or death from any cause, whichever occurs first.
Measured: up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALKStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870733
- Sponsor's protocol ID
- Lungmate-038
- Status last verified
- Jul 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Clinical Study of Iruplinalkib Combined With Bevacizumab as Neoadjuvant Therapy for ALK-positive Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT07870733
- Acronym / sponsor ID
- Lungmate-038
- Conditions
- ALK, NSCLC, Neoadjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 13 Oct 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 single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC. Eligible patients receive 4 cycles (Q3W) of iruplinalkib (60 mg lead-in for 7 days, then 180 mg daily, PO) plus bevacizumab (15 mg/kg, IV, D1). Surgery is performed 4 weeks later, followed by adjuvant iruplinalkib monotherapy for up to 2 years. Primary endpoint is major pathological response (MPR) rate; secondary endpoints include safety, R0 resection rate, and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab combined with iruplinalkib | Experimental | Drug: Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:The neoadjuvant treatment phase consists of 4 cycles (Q3W) of bevacizumab (15 mg/kg, intravenous infusion on day 1 of each cycle) combined with iruplinalkib (oral, with a 7-day lead-in of 60 mg once daily, then escalated to 180 mg once daily if tolerated). Surgery is performed 4 weeks after completion of neoadjuvant therapy, and adjuvant maintenance therapy with iruplinalkib monotherapy (180 mg once daily, for up to 2 years) is initiated within 4-8 weeks post-surgery. Discontinuation criteria include disease progression, unacceptable toxicity, or loss of clinical benefit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent.
- Age 18-80 years, both sexes.
- Histologically or cytologically confirmed NSCLC.
- Stage II-III NSCLC per investigator, and ALK-positive.
- At least one measurable lesion per RECIST 1.1.
Key exclusion criteria (17 listed)
- Hypersensitivity to iruplinalkib, bevacizumab, or any excipients.
- Prior targeted therapy (TKI or mAb), immunotherapy, or investigational drugs for NSCLC.
- Mixed small-cell and non-small-cell histology.
- Other malignancy within 5 years, except cured basal cell carcinoma, early GI cancer (endoscopically resected), cervical CIS, DCIS, papillary thyroid cancer, or other cured cancers deemed not to affect survival.
- Unstable systemic disease: active infection, uncontrolled hypertension (>160/110 mmHg), unstable angina or angina within 3 months, CHF (NYHA ≥II), MI within 6 months, clinically significant arrhythmia requiring treatment, or QTc >480 ms (average of 3 consecutive measurements if prolonged).
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 |
|---|---|---|
| Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:Eligible patients receive 4 cycles (Q3W) of bevacizumab (15 mg/kg IV on D1) plus iruplinalkib (60 mg oral lead-in for 7 days, then 180 mg daily). Surgery is performed 4 weeks after neoadjuvant therapy, followed by adjuvant iruplinalkib monotherapy for up to 2 years (starting within 4-8 weeks post-surgery), continued until progression, unacceptable toxicity, or loss of benefit. | Drug | Bevacizumab combined with iruplinalkib |
Primary outcome
Pathological complete response (pCR) rate
Time frame: up to 30 months
The proportion of subjects undergoing lung cancer resection who have no residual viable tumor cells in both the postoperative tumor bed and lymph nodes.
1 secondary outcome
Progression-free survival (PFS)
Time frame: up to 40 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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for ALK
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingObservational study
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
ALK-positive NSCLC, ALK-Positive Lung Cancer
Not yet recruitingPhase 2
Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma
Infant-Type Hemispheric Glioma
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 study testing Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC: in people with ALK and NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, 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 13 Oct 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.
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 Peng Zhang (13512185932, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: up to 30 months). 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 13 Oct 2026.