A Study of TAS3351 in NSCLC Patients With EGFRmt (TAS3351)

A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: TAS3351

Detailed Description

This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). The dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC participants with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC participants with C797S EGFR mutations.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Institut Gustave Roussy
• Germany
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Universitaetsklinikum Koeln
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
• Netherlands
  • Leiden, Netherlands, 2333ZA
    • Leiden University Medical Center (LUMC)
• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas M. D. Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Oncology - Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Locally advanced, non-resectable or metastatic NSCLC
• Have adequate organ function
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Has tumor tissue available to allow for analysis of EGFRmt status

Dose Escalation:

• Has any EGFRmt status

Dose Escalation back-fill part, Dose Expansion and Phase II:

• Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
• Has measurable disease per response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)

Exclusion Criteria:

• Participating in medical research not compatible with this study
• Symptomatic and unstable central nervous system (CNS) metastases
• Have not recovered from prior cancer treatment
• Have a significant cardiac condition
• Are a pregnant or breastfeeding female
• A serious illness or medical condition
• Unable to swallow or digest pills

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A1: Dose Escalation: 50 mg; Participants received TAS3351 50 milligrams (mg), tablets, orally, once daily (QD), on Days 1-21 of each 21-day cycle, for maximum duration of 66 days.	Drug: TAS3351; Oral tablets.
Experimental: Part A1: Dose Escalation: 100 mg; Participants received TAS3351 100 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 126 days.	Drug: TAS3351; Oral tablets.
Experimental: Part A1: Dose Escalation: 200 mg; Participants received TAS3351 200 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 94 days.	Drug: TAS3351; Oral tablets.
Experimental: Part A1: Dose Escalation: 350 mg; Participants received TAS3351 350 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 46 days.	Drug: TAS3351; Oral tablets.
Experimental: Part A1: Dose Escalation: 500 mg; Participants received TAS3351 500 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 87 days.	Drug: TAS3351; Oral tablets.
Experimental: Part A1: Dose Escalation: 700 mg; Participants were to receive TAS3351 700 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle.	Drug: TAS3351; Oral tablets.
Experimental: Part A2: Backfill; Participants were to be enrolled in Part A2 (backfill) when a dose level in Part A1 was determined to be safe and preliminary antitumor activity was observed.	Drug: TAS3351; Oral tablets.
Experimental: Part B: Dose Expansion; .NSCLC participants with C797S EGFR mutations were planned for enrollment in Part B (dose expansion) and were to receive the recommended Phase 2 dose established in Part A.	Drug: TAS3351; Oral tablets.
Experimental: Part C: Phase 2; NSCLC participants with C797S EGFR mutations were planned for enrollment in Part C (Phase 2) and were to receive the recommended Phase 2 dose established in Part A	Drug: TAS3351; Oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A1: Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug and did not necessarily have a causal relationship to the use of the study drug.	From first dose of the study drug up to 30 days after last dose (up to 21.7 months)
Part A1: Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)	DLTs were defined as adverse events (AEs) graded by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) assessed by the Investigator to be related to study treatment administration during Cycle 1 & included:Hematologic Toxicity;grade 4 neutropenia greater than[>]7days; febrile neutropenia (absolute neutrophil count [ANC] less than(<)1000 per cubic millimeter (1000/mm3) with fever greater than or equal to(≥)38.3 degree celsius (°C) or fever ≥38.0°C for > 1hour); grade 4 thrombocytopenia, Hepatic Toxicity: grade ≥3 total bilirubin >7days; grade 4 total bilirubin; Renal Toxicity:creatinine clearance(CrCl)<30 milliliters per minute (mL/min) for > 3days despite supportive care;Other Nonhematologic Toxicity:grade ≥3 nonhematologic toxicity with: grade 3 nausea, vomiting, diarrhea, or hyperglycemia, prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Any death not clearly attributed to the underlying disease or extraneous causes.	Cycle 1 (cycle length = 21 days)
Part B: Dose Expansion: Percentage of Participants With Objective Response Rate (ORR) by Independent Central Review (ICR)	ORR was the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) according to response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1) criteria. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30 percent (%) decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to less than (<)10 millimeters (mm).	Up to 21.7 months
Part C: Phase 2: Percentage of Participants With ORR by ICR	ORR was the proportion of participants experiencing a PR or CR according to RECIST v1.1 criteria. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10mm.	Up to approximately 21.7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A1: Dose Escalation: Percentage of Participants With ORR	ORR was the proportion of participants experiencing a best overall response of PR or CR according to RECIST v1.1 criteria. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10mm.	From first dose of the study drug up to 30 days after the last dose (up to approximately 21.7 months)
Part A1: Dose Escalation: Duration of Response (DoR)	DOR was calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10 mm.	From first dose of the study drug up to 30 days after the last dose (up to approximately 21.7 months)
Part A1: Dose Escalation: Percentage of Participants Exhibiting Disease Control Rate (DCR)	DCR was the proportion of participants who achieved a CR, PR, or stable disease (SD). Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis <10 mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study.	From first dose of the study drug up to 30 days after the last dose (up to approximately 21.7 months)
Part A2: Backfill: Number of Participants Exhibiting Progression Free Survival (PFS)	PFS was defined as the time from date of first dose to the date of documentation of disease progression, or date of death, whichever occurred first.	From first dose of the study drug up to 30 days after the last dose (up to 21.7 months)
Part A2: Backfill: Number of Participants Exhibiting Overall Survival (OS)	OS was measured from the date of first dose until the date of death due to any cause.	From first dose of the study drug up to 30 days after the last dose (up to 21.7 months)
Part A1: Dose Escalation: Maximum Plasma Concentration (Cmax) of TAS3351	Cmax is the maximum observed plasma concentration within the dosing interval. Blood samples for pharmacokinetic (PK) analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: Area Under The Plasma Concentration-Time Curve (AUC24) of TAS3351	AUC24 is the area under the curve from the time of dosing up to time 24hours. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: Area Under The Plasma Concentration-Time Curve (AUCinf) of TAS3351	AUCinf is the area under the plasma concentration-time curve from time of dosing extrapolated to infinity. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose
Part A1: Dose Escalation: Time To Maximum Plasma Concentration (Tmax) of TAS3351	Tmax is the time to maximum plasma concentration within the dosing interval. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: Terminal Elimination Half-Life (T½) of TAS3351	T1/2 is the terminal elimination half-life. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose
Part A1: Dose Escalation: Cmax of Metabolite TAS-05-14317	Cmax is the maximum observed plasma concentration within the dosing interval. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: AUC24 of Metabolite TAS-05-14317	AUC24 is the area under the curve from the time of dosing up to time 24hours. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: AUCinf of Metabolite TAS-05-14317	AUCinf is the area under the plasma concentration-time curve from time of dosing extrapolated to infinity. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose
Part A1: Dose Escalation: Tmax of Metabolite TAS-05-14317	Tmax is the time to maximum plasma concentration within the dosing interval. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose; Cycle 1 Day 15: Pre-dose and at multiple timepoints up to 24 hours post dose
Part A1: Dose Escalation: T½ of Metabolite TAS-05-14317	T1/2 is the terminal elimination half-life. Blood samples for PK analysis were collected at specified timepoints. A PK lead-in with a single TAS3351 dose on Cycle 1 Day -3, followed by PK sampling three days before the start of continuous daily dosing, was included to characterize the PK profile.	Cycle 1 Day -3: Pre-dose and at multiple timepoints up to 72 hours post dose
Part B: Dose Expansion and Part C: Phase 2: Number of Participants With TEAEs	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that is starting or worsening at the time of or after the first dose of study drug administration and within 30 days after the last dose of study drug and did not necessarily have a causal relationship to the use of the study drug.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: DoR by ICR	DOR was calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10 mm.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: PFS by ICR	PFS is the time from date of first dose to the date of documentation of disease progression, or date of death, whichever occurs first.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: DCR by ICR	DCR was the proportion of participants who achieved a CR, PR, or SD. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis <10 mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: ORR by Investigator Assessment	ORR was the proportion of participants experiencing a PR or CR according to RECIST v1.1 criteria. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10mm.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: DoR by Investigator Assessment	DOR was calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10 mm.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: PFS by Investigator Assessment	PFS was defined as the time from date of first dose to the date of documentation of disease progression, or date of death, whichever occurred first.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: DCR by Investigator Assessment	DCR was the proportion of participants who achieved a CR, PR, or SD. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis <10 mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: Intracranial ORR (icORR) by Investigator Assessment	The icORR was defined as percentage of participants experiencing a PR or CR. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10mm. The icORR was planned to be assessed based on ORR of central nerve system (CNS) lesions only.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: Intracranial DoR (icDOR) by Investigator Assessment	The icDoR was planned to be calculated for all responders from the date of first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Evaluation of target lesions defined a CR as the disappearance of all target lesions and non-target lesions (if applicable), and normalization of tumor marker level; PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum of diameters for all target lesion assessments. Evaluation of non-target lesions was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. For both target and non-target evaluations, any pathological lymph node must have had a reduction in short axis to <10 mm. The icDoR was planned to be assessed based on DoR of CNS lesions only.	Up to approximately 21.7 months
Part B: Dose Expansion and Part C: Phase 2: OS	OS was measured from the date of first dose until the date of death due to any cause.	Up to approximately 21.7 months
Part C: Phase 2: Participant Reported Outcome Assessed by European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)	The EORTC QLQ-C30 is a 30-item questionnaire meant to assess different aspects that define the quality of life of cancer participants and survivors. It facilitates insights into participants' physical, emotional, and social wellbeing, ultimately supporting more informed treatment decisions and care strategies. The questionnaire is divided into 4 parts, namely global health status/ quality of life, functional scales, symptom scales and single-item symptoms. Each item was meant to be scored on a scale of 1 (Not at all) to 4 (Very much). Scores obtained from each section are transformed to a 0-100 score. For the functional and global health status scales, higher scores indicate better functioning or quality of life. For symptom scales and single-item measures, higher scores indicate greater symptom severity.	Up to approximately 21.7 months
Part C: Phase 2: Participant Reported Outcome Assessed by EuroQol 5D-5L Questionnaire	The EQ-5D-5L is a standardized, generic, participant-reported instrument developed by the EuroQol Group to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participants were to rate five dimensions namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item is scores on a score of 1 (no problems) to 5 (extreme problems). The combination of responses forms a 5-digit health state which is converted into a single utility index score using a country-specific value set. Higher utility scores indicate better health-related quality of life.	Up to approximately 21.7 months

Collaborators and Investigators

• Sponsor: Taiho Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Non-Small Cell Lung Cancer; EGFR mutation; C797S mutation; TAS3351
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 10073010; 2022-502595-23-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No