ALK-positive Non Small Cell Lung CancerPhase 2NCT07771764
A Multicenter Exploratory Clinical Study of Iruplaltinib Combined With Pemetrexed as Neoadjuvant Therapy for Resectable ALK-Positive Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing iruplaltinib and pemetrexed in people with ALK-positive Non Small Cell Lung Cancer, run by First Affiliated Hospital of Fujian Medical University at 7 sites in China.
Trial summary
This is a single-arm clinical study planning to enroll 30 treatment-naive patients with resectable ALK-positive non-squamous non-small cell lung cancer (NSCLC). The study consists of two phases: a safety lead-in phase and an expansion phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ALK-positive Non Small Cell Lung Cancer
- What is being tested?
- iruplaltinib and pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesChina
- Study dates
- 1 Aug 2026to 1 Dec 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and provide written informed consent.
- Aged between 18 and 75 years inclusive.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) via core needle biopsy; stage IIA-IIIB disease assessed by the investigator; confirmed ALK-positive status by genetic testing.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The primary NSCLC is considered potentially completely resectable based on multidisciplinary team (MDT) evaluation, which must include a thoracic surgeon specialized in oncologic surgery.
- At least one measurable lesion per RECIST version 1.1.
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- Expected survival duration ≥ 3 months.
- Able to swallow oral tablets intact.
- Pulmonary function sufficient to tolerate surgical resection.
- No administration of any blood products or hematopoietic growth factors within 14 days prior to the first study drug dose.
- Adequate function of other major organs (liver, kidney, hematologic system, etc.) meeting all of the following criteria: Absolute neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN). For participants diagnosed with Gilbert's syndrome, TBIL ≤ 3.0 × ULN with direct bilirubin (DBIL) ≤ 1.5 × ULN; Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; if liver metastases are present, ALT and AST ≤ 5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Urine protein < 2+; if urine protein ≥ 2+, 24-hour urinary protein quantification ≤ 1 g; International normalized ratio (INR) ≤ 1.5 (for participants not receiving anticoagulant therapy).
- For women of childbearing potential without surgical sterilization: serum or urine human chorionic gonadotropin (HCG) test must be negative within 7 days before the first study dose. They must not be breastfeeding and must adopt a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) throughout study treatment and for 3 months after the last dose of study treatment.
- Men who have not undergone sterilization must agree to use effective contraception for at least 120 days during the study.
Who cannot join
- Prior receipt of any systemic anti-tumor therapy for NSCLC, including chemotherapy, biotherapy, immunotherapy or any investigational agent, or prior locoregional radiotherapy.
- Pathological diagnosis of mixed small cell lung cancer, small cell lung cancer, or squamous non-small cell lung cancer.
- History of malignancies other than NSCLC within 5 years prior to enrollment, except cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma resected endoscopically, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured malignancy deemed not to affect survival related to current NSCLC.
- Participation in another clinical study or receiving other investigational products; or receipt of other investigational products within 4 weeks before the first dose of study drug. The interval from the last dose of other anti-tumor therapy to the first study drug is less than 2 weeks if the half-life ≤ 3 days, or less than 4 weeks if the half-life > 3 days.
- Presence of any unstable systemic disease (including uncontrolled diabetes, thyroid disorders, active infection, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite antihypertensive treatment)).
- Any clinically significant cardiovascular or cerebrovascular disease within 6 months prior to the first study drug administration, such as unstable angina, congestive heart failure (NYHA Class II or higher), myocardial infarction, cerebrovascular accident (including transient ischemic attack).
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- Atrial fibrillation or ventricular fibrillation of any grade; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; QTc >450 ms (male); QTc >470 ms (female). Use of drugs that may prolong QT interval or induce torsades de pointes within 14 days before the first dose or during the study.
- Pleural effusion, ascites or pericardial effusion requiring drainage. Patients may be enrolled if symptoms are assessed stable by the investigator after drainage.
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Use of corticosteroids (dose >10 mg/day prednisone or equivalent) within 2 weeks before enrollment, continuous corticosteroid use for more than 30 days, or requirement for long-term corticosteroids or other immunosuppressants.
- Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or positive hepatitis C virus antibody.
- Risk of gastrointestinal perforation or bowel obstruction; presence of nausea, vomiting or diarrhea ≥Grade 1 (CTCAE Version 6.0); other gastrointestinal dysfunction or gastrointestinal diseases that may affect drug absorption, distribution, metabolism or excretion (e.g., ulcerative disorders or malabsorption syndrome).
- Receipt of other major surgical procedures (excluding diagnostic procedures) within 4 weeks prior to study initiation, or planned major surgery during the study.
- Known hypersensitivity to study drugs or any excipients.
- Unable to discontinue strong CYP3A4 inducers or inhibitors at least 1 week before study entry or requiring concomitant use of such agents during the study. Examples include but are not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, rifapentine, tipranavir, ritonavir, St. John's Wort, ketoconazole. Unable to discontinue drugs mainly metabolized by CYP3A4 with narrow therapeutic index at least 1 week before study entry or requiring administration during the study, including but not limited to crizotinib, ceritinib, alectinib, erythromycin, atorvastatin.
- Administration of live vaccines within 4 weeks prior to study treatment or planned live vaccination during the study.
- Previous history of extensive bilateral diffuse interstitial fibrosis, or known Grade 3 or 4 interstitial fibrosis / interstitial lung disease, including pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, bronchiolitis obliterans and pulmonary fibrosis. History of localized radiation pneumonitis or radiation pulmonary fibrosis is excluded.
- Pregnant or breastfeeding women.
- Illicit drug use, chronic alcohol abuse or other harmful addictions; neurological or psychiatric disorders leading to poor compliance.
- Other conditions deemed inappropriate for enrollment at the investigator's discretion.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Fuzhou Pulmonary Hospital
Fuzhou, Fujian
Xinfu Chen
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian
Tianxing Guo
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Fancai Lai, +86 13799959809, Laifancai@163.com
The Second Hospital of Longyan
Longyan, Fujian
Rongxing Liu
The Second Attached Hospital of Fujian Medical University
Quanzhou, Fujian
Jiansheng Yang
Xiamen Medical College Affiliated Second Hospital
Xiamen, Fujian
Jiefang Sheng
Zhangzhou Hospital
Zhangzhou, Fujian
Yi Zhang
About this study
This is a single-arm clinical study planning to enroll 30 treatment-naive patients with resectable ALK-positive non-squamous non-small cell lung cancer (NSCLC). The study consists of two phases: a safety lead-in phase and an expansion phase.
Safety Lead-in Phase A total of 6 subjects will be enrolled and treated with the regimen: iruplaltinib 60 mg orally once daily on Days 1-7, followed by 180 mg orally once daily starting on Day 8, combined with pemetrexed 500 mg/m² intravenously every 3 weeks for one cycle (3 weeks).
Read more
Adopting the modified Toxicity Probability Interval-2 (mTPI-2) design with a target dose-limiting toxicity (DLT) rate of 30%, DLTs occurring within the 21-day observation period after the first dose among the 6 subjects will be evaluated. Unlike standard mTPI-2 design with decisions of "stay" or "escalate", if the decision in this safety lead-in phase is "stay" or "escalate", the lead-in phase will be completed and the study will proceed to the expansion phase. If the decision is "de-escalate" or "exclude this dose from the study", the study will be terminated.
Expansion Phase Eligible screened patients will receive iruplaltinib (60 mg po QD d1-7; then 180 mg po QD starting on Day 8) plus pemetrexed (500 mg/m² iv Q3W). Patients will receive 6 weeks of pre-operative treatment followed by curative resection, which is scheduled to be performed within 4 weeks after completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent therapy such as alectinib or brigatinib at the investigator's discretion. Four weeks after curative surgery, patients will receive adjuvant iruplaltinib for up to 2 years.
- Conditions
- ALK-positive Non Small Cell Lung Cancer
- Being tested
- iruplaltinib and pemetrexed
- Keywords
- NSCLC, ALK positive, neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iruplaltinib and pemetrexedDrug
Treatment with iruplaltinib (60 mg po QD on Days 1-7; followed by 180 mg po QD starting on Day 8) combined with pemetrexed (500 mg/m² iv Q3W). Patients receive 6 weeks of preoperative treatment followed by curative resection, which is scheduled to be performed within 4 weeks upon completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent treatment such as alectinib or brigatinib at the investigator's discretion. Adjuvant iruplaltinib will be administered 4 weeks after curative surgery for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Treatment with iruplaltinib (60 mg po QD on Days 1-7; followed by 180 mg po QD starting on Day 8) combined with pemetrexed (500 mg/m² iv Q3W). Patients receive 6 weeks of preoperative treatment followed by curative resection, which is scheduled to be performed within 4 weeks upon completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent treatment such as alectinib or brigatinib at the investigator's discretion. Adjuvant iruplaltinib will be administered 4 weeks after curative surgery for up to 2 years. Receives: Drug: iruplaltinib and pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
Proportion of patients achieving major pathological response (≤10% viable tumor cells in resected specimen) after neoadjuvant therapy.
Measured: Up to 4 weeks after curative resection
Secondary outcomes (8)
Pathological Complete Response Rate
Proportion of patients achieving pathological complete response (no viable tumor cells in primary lesion and resected lymph nodes) after neoadjuvant therapy.
Measured: Up to 4 weeks after curative resection
Objective Response Rate
Proportion of patients with confirmed complete response (CR) or partial response (PR) assessed by RECIST v1.1 during neoadjuvant treatment
Measured: Up to 6 weeks, at completion of neoadjuvant treatment
Disease Control Rate
Proportion of patients achieving confirmed CR, PR or stable disease (SD) assessed by RECIST v1.1 during neoadjuvant treatment.
Measured: Up to 6 weeks, at completion of neoadjuvant treatment
R0 Resection Rate
Proportion of patients undergoing R0 curative resection
Measured: Within 4 weeks after completion of neoadjuvant therapy
Event-Free Survival
Time from study treatment initiation to first documented disease progression, recurrence, death from any cause, or unresectable disease.
Measured: Up to 60 months from study treatment initiation
Disease-Free Survival
Time from curative R0 resection to disease recurrence or death from any cause
Measured: Up to 60 months after curative resection
Overall Survival
Time from study treatment initiation to death from any cause
Measured: Up to 60 months from study treatment initiation
Treatment-Emergent Adverse Events
Incidence, type, severity and relatedness of adverse events occurring after study treatment initiation.
Measured: From first dose of study treatment up to 28 days after last study treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771764
- Sponsor's protocol ID
- QL-NSCLC-QIXK-3009
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A definitive IPD sharing framework is pending institutional and ethical review. Current institutional and privacy rules prevent external release of de-identified individual participant data until a formal sharing policy is fully approved. This trial registration will be updated immediately after the sponsor and ethics committee reach a clear decision on data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Exploratory Clinical Study of Iruplaltinib Combined With Pemetrexed as Neoadjuvant Therapy for Resectable ALK-Positive Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07771764
- Acronym / sponsor ID
- QL-NSCLC-QIXK-3009
- Conditions
- ALK-positive Non Small Cell Lung Cancer
- Keywords
- NSCLC, ALK positive, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 18 Aug 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-arm clinical study planning to enroll 30 treatment-naive patients with resectable ALK-positive non-squamous non-small cell lung cancer (NSCLC). The study consists of two phases: a safety lead-in phase and an expansion phase.
Safety Lead-in Phase A total of 6 subjects will be enrolled and treated with the regimen: iruplaltinib 60 mg orally once daily on Days 1-7, followed by 180 mg orally once daily starting on Day 8, combined with pemetrexed 500 mg/m² intravenously every 3 weeks for one cycle (3 weeks).
Adopting the modified Toxicity Probability Interval-2 (mTPI-2) design with a target dose-limiting toxicity (DLT) rate of 30%, DLTs occurring within the 21-day observation period after the first dose among the 6 subjects will be evaluated. Unlike standard mTPI-2 design with decisions of "stay" or "escalate", if the decision in this safety lead-in phase is "stay" or "escalate", the lead-in phase will be completed and the study will proceed to the expansion phase. If the decision is "de-escalate" or "exclude this dose from the study", the study will be terminated.
Expansion Phase Eligible screened patients will receive iruplaltinib (60 mg po QD d1-7; then 180 mg po QD starting on Day 8) plus pemetrexed (500 mg/m² iv Q3W). Patients will receive 6 weeks of pre-operative treatment followed by curative resection, which is scheduled to be performed within 4 weeks after completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent therapy such as alectinib or brigatinib at the investigator's discretion. Four weeks after curative surgery, patients will receive adjuvant iruplaltinib for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: iruplaltinib and pemetrexedTreatment with iruplaltinib (60 mg po QD on Days 1-7; followed by 180 mg po QD starting on Day 8) combined with pemetrexed (500 mg/m² iv Q3W). Patients receive 6 weeks of preoperative treatment followed by curative resection, which is scheduled to be performed within 4 weeks upon completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent treatment such as alectinib or brigatinib at the investigator's discretion. Adjuvant iruplaltinib will be administered 4 weeks after curative surgery for up to 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily participate in this study and provide written informed consent.
- Aged between 18 and 75 years inclusive.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) via core needle biopsy; stage IIA-IIIB disease assessed by the investigator; confirmed ALK-positive status by genetic testing.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The primary NSCLC is considered potentially completely resectable based on multidisciplinary team (MDT) evaluation, which must include a thoracic surgeon specialized in oncologic surgery.
Key exclusion criteria (20 listed)
- Prior receipt of any systemic anti-tumor therapy for NSCLC, including chemotherapy, biotherapy, immunotherapy or any investigational agent, or prior locoregional radiotherapy.
- Pathological diagnosis of mixed small cell lung cancer, small cell lung cancer, or squamous non-small cell lung cancer.
- History of malignancies other than NSCLC within 5 years prior to enrollment, except cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma resected endoscopically, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured malignancy deemed not to affect survival related to current NSCLC.
- Participation in another clinical study or receiving other investigational products; or receipt of other investigational products within 4 weeks before the first dose of study drug. The interval from the last dose of other anti-tumor therapy to the first study drug is less than 2 weeks if the half-life ≤ 3 days, or less than 4 weeks if the half-life > 3 days.
- Presence of any unstable systemic disease (including uncontrolled diabetes, thyroid disorders, active infection, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite antihypertensive treatment)).
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 |
|---|---|---|
| iruplaltinib and pemetrexedTreatment with iruplaltinib (60 mg po QD on Days 1-7; followed by 180 mg po QD starting on Day 8) combined with pemetrexed (500 mg/m² iv Q3W). Patients receive 6 weeks of preoperative treatment followed by curative resection, which is scheduled to be performed within 4 weeks upon completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent treatment such as alectinib or brigatinib at the investigator's discretion. Adjuvant iruplaltinib will be administered 4 weeks after curative surgery for up to 2 years. | Drug | Experimental |
Primary outcome
Major Pathological Response Rate
Time frame: Up to 4 weeks after curative resection
Proportion of patients achieving major pathological response (≤10% viable tumor cells in resected specimen) after neoadjuvant therapy.
8 secondary outcomes
Pathological Complete Response Rate
Time frame: Up to 4 weeks after curative resection
Objective Response Rate
Time frame: Up to 6 weeks, at completion of neoadjuvant treatment
Disease Control Rate
Time frame: Up to 6 weeks, at completion of neoadjuvant treatment
R0 Resection Rate
Time frame: Within 4 weeks after completion of neoadjuvant therapy
Event-Free Survival
Time frame: Up to 60 months from study treatment initiation
Disease-Free Survival
Time frame: Up to 60 months after curative resection
Overall Survival
Time frame: Up to 60 months from study treatment initiation
Treatment-Emergent Adverse Events
Time frame: From first dose of study treatment up to 28 days after last study treatment dose
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 18 Aug 2026.
- Individual participant dataSharing planned: No. A definitive IPD sharing framework is pending institutional and ethical review. Current institutional and privacy rules prevent external release of de-identified individual participant data until a formal sharing policy is fully approved. This trial registration will be updated immediately after the sponsor and ethics committee reach a clear decision on data sharing.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iruplaltinib and pemetrexed in people with ALK-positive Non Small Cell Lung Cancer, run by First Affiliated Hospital of Fujian Medical University at 7 sites 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 20 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Fancai Lai (+86 13799959809, Laifancai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: Up to 4 weeks after curative resection). 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 18 Aug 2026.