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Can a Two-Drug punch before surgery beat ALK-Positive lung cancer?

NCT ID NCT07771764

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fuzhou Pulmonary Hospital

    Fuzhou, Fujian, China

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • The Second Attached Hospital of Fujian Medical University

    Quanzhou, Fujian, China

  • The Second Hospital of Longyan

    Longyan, Fujian, China

  • Xiamen Medical College Affiliated Second Hospital

    Xiamen, Fujian, China

  • Zhangzhou Hospital

    Zhangzhou, Fujian, China

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