Can a Two-Drug punch before surgery beat ALK-Positive lung cancer?
NCT ID NCT07771764
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial is testing whether giving a combination of iruplaltinib and pemetrexed before surgery can shrink tumors in people with early-stage ALK-positive non-small cell lung cancer. The goal is to see if this pre-treatment improves the chance of removing all cancer during surgery and reduces the risk of it coming back. Participants receive the drugs for six weeks, then undergo surgery, followed by up to two years of iruplaltinib to help prevent recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iruplaltinib combined with pemetrexed
- What this could lead to
- If successful, this approach could shrink tumors before surgery, potentially increasing the chance of complete removal and long-term remission in ALK-positive lung cancer.
- What could go wrong
- This is a small, early-phase study (30 patients) without a comparison group. The combination may cause side effects, and the benefit over standard care is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuzhou Pulmonary Hospital
Fuzhou, Fujian, China
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Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
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The Second Attached Hospital of Fujian Medical University
Quanzhou, Fujian, China
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The Second Hospital of Longyan
Longyan, Fujian, China
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Xiamen Medical College Affiliated Second Hospital
Xiamen, Fujian, China
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Zhangzhou Hospital
Zhangzhou, Fujian, China
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