Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

PHASE3RECRUITING

The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).

Study details:

This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) versus placebo in participants with resected early stage NSCLC harboring uncommon EGFRmt. Approximately 360 participants will be randomized to:. Arm A: Zipalertinib twice daily (BID) monotherapy OR.

Arm B: Placebo BID monotherapy. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States [US]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt: exon20 insertion mutations (ex20ins) or other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
Magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain done prior to surgery. Participants in whom this was not done prior to surgery may still be enrolled if appropriate imaging (i.e., MRI or CT of the brain) is performed prior to randomization.
Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Resection may be accomplished by open thoracotomy or video associated thoracic surgery (VATS) techniques.
Classified post-operatively as either Stage IB, IIA, IIB, or IIIA according to the tumor nodes metastasis (TNM) staging system for lung cancer (American Joint Committee on Cancer [AJCC] 9th edition).
Complete recovery from surgery at the time of randomization.
Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.

Exclusion criteria

Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
Treatment with any of the following within the time frame specified: Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time. Pre-operative or post-operative or planned radiation therapy for the current lung cancer. Any prior systemic anticancer therapy (e.g., neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC. Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study treatment. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate cytochrome p450 (CYP) 3A4 inducers or inhibitors within 7 days prior to first dose. Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
Has received only segmentectomies or wedge resections.
Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
Impaired cardiac function or clinically significant cardiac disease.
Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).
Participants with a history of any other cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, other cancers curatively treated with no evidence of disease for >5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment. Screening not required.
Active bleeding disorders.
Known: Hypersensitivity: i. To the ingredients in zipalertinib/placebo or any drugs similar in structure or class. ii. To platinum-containing drugs (i.e., cisplatin, carboplatin), pemetrexed, or any known excipients of these drugs. b. Contraindications to platinum-containing drugs (i.e., cisplatin, carboplatin) or pemetrexed according to the respective local labels.
Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12 supplementation during treatment with pemetrexed.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE3

Study ID

NCT07128199

Intervention or treatment

DRUG: Cisplatin

DRUG: Carboplatin

DRUG: Pemetrexed

DRUG: TAS6417

DRUG: Zipalertinib Matching-placebo

Conditions

Lung Cancer
Adjuvant
Post-surgical
EGFR
Exon 20
Early Stage Lung Cancer
Uncommon EGFR Mutations
NSCLC, Early Stage

Condition: Lung Cancer, Adjuvant and more
DRUG: Cisplatin and other drugs
Bankstown, New South Wales, Australia and more
Sponsor: Taiho Oncology, Inc.

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Research sites nearby

Closest Location:

Bankstown-Lidcombe Hospital

Select from list below to view details:

Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
GenesisCare - North Shore
St Leonards, New South Wales, Australia
Saint John of God - Subiaco Hospital
Subiaco, Western Australia, Australia

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Who is running the clinical trial?

TOI

Taiho Oncology, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Zipalertinib Participants will receive zipalertinib orally until the participant meets any of the treatment discontinuation criteria.	Drug: TAS6417
PLACEBO_COMPARATOR: Placebo Participants will receive zipalertinib matching-placebo, until the participant meets any of the treatment discontinuation criteria.	Drug: Zipalertinib Matching-placebo

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Disease-free Survival (DFS) as Assessed by the Investigator	Not Specified	Up to 5 years

Secondary Outcome

Measure	Description	Time Frame
Disease-free Survival Rate	Not Specified	At 2, 3 and 5 years
Overall Survival (OS)	Not Specified	Up to 5 years
Overall Survival Rate	Not Specified	At 2, 3 and 5 years
DFS of Central Nervous System (cDFS)	Not Specified	Up to 5 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)	Not Specified	Up to 5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters	Not Specified	Up to 5 years
Number of Participants with Clinically Significant Changes in Vital Signs	Not Specified	Up to 5 years
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters	Not Specified	Up to 5 years
Number of Participants With Change in Left Ventricular Ejection Fraction (LVEF) Evaluated Using Electrocardiography (ECHO) and Multigated Acquisition (MUGA) Scan	Not Specified	Up to 5 years
Change in EuroQuality of Life-5 Dimensional 3-Level (EQ-5D-3L)	EQ-5D-3L is a standardized measure of the participant's health-related quality of life (QoL). EQ-5D is a 5-item questionnaire that assesses 5 domains including 1. mobility, 2. self-care, 3. usual activities, 4. pain/discomfort and 5. anxiety/depression. Each dimension has 3 levels ranging from no problems to extreme problems. Higher scores indicate improvement in status of health. The responses will be used to derive overall score using a visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline, up to 5 years
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scores	EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement.	Up to 5 years

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References

Clinical Trials Gov: A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

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