Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Mobocertinib

Participants diagnosed with advanced NSCLC with EGFR exon 20 insertions (ex20ins) mutations who were treated according to routine clinical practice will be observed retrospectively up to 6 months or until the end of follow-up.

Study Director

The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

This is a retrospective, observational study in participants with advanced NSCLC with EGFR exon-20 driven mutations. This study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (HCRU) in a routine clinical practice setting in the real world.

The study will enroll approximately 218 participants. Participants who were treated at the participating sites between 01 January 2017 and 30 November 2021 will be included. The data will be collected retrospectively at the specialized centers from the participants medical records and notes. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC With EGFR Exon-20 Mutations

This multi-center study will be conducted in Canada, France and Hong Kong. The overall duration of the study will be 6 months.

A Chart Review Study of Adults With Advanced NSCLC

Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

rwPFS is defined as the time elapsed from the initiation of a new treatment line to real-world progressive disease (rwPD) or death, whichever occurred first. rwPD: unequivocal increase in visible disease/disease burden or presence of new lesions. Participants will be censored at the end of the line of therapy or date of last contact available.

Overall response rate (ORR) is the percentage of participants on a treatment line who achieve real-world complete response (rwCR) or real-world partial response (rwPR) as best response per treatment line. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some, or all, areas without any increase in visible disease.

ORR is the percentage of participants on a treatment line who achieve confirmed rwCR or rwPR as best response per treatment line. Confirmed responses are responses that persist greater than or equal to (\>=) 4 weeks after initial response. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some or all areas without any increase in visible disease.

rwDOR is defined as the time from the date of first rwCR or rwPR after treatment initiation to the date of the first noted occurrence of progressive disease or death. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.

rwDCR is defined as the percentage of participants who have a rwCR, rwPR, or real-world stable disease (rwSD) assessment during the course of a line of therapy, among all participants in that cohort. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease, rwSD: no change in overall size of visible disease, or mixed response (some lesions increased, some lesions decreased).

OS is defined as the time from the date of advanced disease diagnosis until the date of death. Participants for whom a date of death has not been identified, will be censored at the date of last contact available.

rwTTD is defined as time from treatment initiation to treatment discontinuation for any reason. Treatment discontinuation is defined as the date of the last drug administered during the same treatment line of therapy or death, whichever occurs earlier. Participants are considered to discontinue treatment if they have advanced to a new line of therapy since the last drug administration, have a recorded date of death, or have no visit activity more than 120 days after the last drug administration.

Takeda

Amino Acids

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Mobocertinib 40 milligrams (mg) (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle for up to disease progression or intolerable toxicity, or another discontinuation criterion, and increasing until 160 mg, once daily (for up to approximately 10-12 cycles).

Mobocertinib 160 mg, once daily, for up to approximately 10-12 cycles.

This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of the study.

The main aim of the 1st part of the study is to check how much Mobocertinib adults with non-small cell lung cancer (NSCLC) can receive without getting side effects from it.

The main aim of the 2nd part of the study is to learn if the condition of adults with non-small cell lung cancer improves after treatment with Mobocertinib. Another aim is to continue checking for side effects from Mobocertinib.

In the 1st part of the study, at the first visit, the study doctor will check who can take part. For those that can take part, participants will take a capsule of Mobocertinib once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of Mobocertinib. The study doctors will check for side effects after each dose of TAK 788. In this way, researchers can work out the best dose of Mobocertinib to give participants in the 2nd part of the study.

Participants will visit the clinic 30 days after their treatment has finished for a final check-up.

In the 2nd part of the study, at the first visit, the study doctor will check who can take part. Participants will receive the best dose of Mobocertinib worked out from the 1st part of the study. Participants will receive Mobocertinib in the same way as those from the 1st part of the study. The study doctors will learn if the condition of these participants improves after treatment with Mobocertinib. The study doctors will also check for side effects from Mobocertinib.

After treatment has finished, participants will visit the clinic every 12 weeks until the end of the study.

In both parts of the study, participants can receive Mobocertinib for up to just over 1 year, or longer if their condition stays improved.

The drug being tested in this study is called Mobocertinib. Mobocertinib is being tested to treat Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part), Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of Mobocertinib orally administered once daily, and will determine a RP2D. Phase 2 study will look at the efficacy and safety of Mobocertinib in treatment naive Japanese NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned to Phase 1 part or Phase 2 part and will be asked to take Mobocertinib capsule as following dosage and regimen;

Phase 1 part; Mobocertinib, 40 mg as starting dose, once daily, and escalating up to 160 mg until a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further confirm safety observations following identification of MTD/RP2D.

Phase 2 part; Mobocertinib, 160 mg, once daily

The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part; 30).

This multi-center trial will be conducted in Japan. The overall time to participate in this study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.

A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

A Phase 1/2 Study of the Oral EGFR/HER2 Inhibitor TAK-788 in Japanese Non-Small Cell Lung Cancer Patients

The RP2D was the maximum tolerated dose (MTD) or less. The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. The dose recommended for use in phase 2 part was analyzed on the basis of the safety and tolerability data obtained in phase 1 part of the study.

Confirmed ORR is defined as percentage of participants who were confirmed to had achieved complete response (CR) or partial response (PR) per IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. Confirmed responses were responses that persisted on repeat imaging \>=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 millimeter (mm) in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in sum of the longest diameters (SLD) of target lesions, taking as reference baseline sum diameters. The SLD must also demonstrate an absolute increase of at least 5 mm.

DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any \>=grade (G) 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities(nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting \<3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,\>38.3 degree Celsius \[C\]); absolute neutrophil count \<0.5\*10\^9 per liter \[/L\]); prolonged G4 neutropenia (\>=7 days) (if granulocyte-colony stimulating factor \[G-CSF\] required, event considered as DLT irrespective of the duration); neutropenic infection:\>=G3 neutropenia with \>=G3 infection; thrombocytopenia \>=G3 with bleeding, \>=G3 requiring platelet transfusion or G4 without bleeding lasting \>=7 days. Missed \>=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle.

DLT was defined as drug-related toxicity which met one of the following criteria and occurred within the first 28 days of study treatment (Cycle 1): Non-hematologic toxicities any \>=G 3 non-hematologic toxicity, with exception of self-limiting or medically controllable toxicities (nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting \<3 days, excluding alopecia. Hematologic toxicities: febrile neutropenia not related to underlying disease (fever,\>38.3 degree C); absolute neutrophil count \<0.5\*10\^9/L); prolonged G4 neutropenia (\>=7 days) (if granulocyte-colony stimulating factor \[G-CSF\] required, event considered as DLT irrespective of the duration); neutropenic infection: \>=G3 neutropenia with \>=G3 infection; thrombocytopenia \>=G3 with bleeding, \>=G3 requiring platelet transfusion or G4 without bleeding lasting \>=7 days. Missed \>=25% of planned doses of drug over 28 days due to treatment-related AEs in first cycle.

The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort.

Rac (AUC 24) was calculated as the ratio of drug concentrations observed during a dosing interval at steady state divided by drug concentrations seen during the dosing interval after a single (first) dose. Rac (AUC 24) = AUC(0-24) on Cycle 2 Day 1/ AUC(0-24) on Cycle 1 Day 1.

Investigator assessed ORR using RECIST version 1.1 in participants with EGFR mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging \>=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters. All participants with ORR had documentation of EGFR exon 20 insertion mutation.

Investigator assessed ORR using RECIST version 1.1 in participants with HER2 mutations. ORR was defined as the percentage of participants achieving CR and PR per RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging \>=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.

Confirmed ORR was defined as the percentage of the participants who were confirmed to have achieved CR or PR per the investigator using RECIST version 1.1. Confirmed responses were responses that persisted on repeat imaging \>=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.

Duration of response as assessed by the IRC was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm.

Duration of response as assessed by the investigator was defined as the time interval from first documentation of CR/PR (whichever is first recorded) until the first date that PD is objectively documented. CR (target lesion response):disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD. PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest); PD (non-target lesion response): Unequivocal progression of existing non-target lesions. The SLD must also demonstrate an absolute increase of at least 5 mm.

Time to response as assessed by the IRC was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.

Time to response as assessed by the investigator was defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for participants with confirmed CR/PR. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.

DCR as assessed by IRC was defined as percentage of participants achieved CR, PR, stable disease (SD) (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug.CR(target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis.CR(non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level.PR(target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD(target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions.

DCR as assessed by investigator was defined as percentage of participants achieved CR, PR, SD (measurements must had met SD criteria at least once after study entry at minimum interval of 42 days) after initiation of study drug. CR (target lesion): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 mm in short axis. CR (non-target lesion): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in SLD of target lesions, taking as reference baseline sum diameters.SD (target lesion): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD(target lesion): SLD increased by at least 20% from smallest value on study, SLD must also demonstrate an absolute increase of at least 5 mm.PD (non-target lesion): unequivocal progression of existing non-target lesions.

PFS as assessed by the IRC was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions.

PFS as assessed by the investigator was defined as the time interval from the start of study treatment until to the first documentation of PD or death due to any cause (whichever comes first) according to RECIST version 1.1.PD (target lesion response): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. PD (non-target lesion response): unequivocal progression of existing non-target lesions.

OS was defined as the interval from the date of the first dose of the study treatment until death due to any cause.

EORTC QLQ-C30, version 3.0 was a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); a global health status (GHS)/quality-of-life (QoL) scale; and a six single-item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores converted into scale scores ranging from 0 to 100. For functional and GHS/QoL scales, higher scores represent better HRQoL (positive change from Baseline=improvement), for symptom scales lower scores represent better QoL (i.e., a low level of symptomatology/problems) (negative change from Baseline=improvement), and for six-single item scale, lower scores represent better HRQoL (negative change from Baseline=improvement).

HRQOL scores was assessed with EORTC, it is a lung cancer module QLQ-LC13, version 3.0. QLQ-LC13 included 13 questions (4-point scale where 1=Not at all \[best\] to 4=Very much \[worst\]) assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain \[chest, arm or shoulder, other parts\]), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Subscale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Mobocertinib 40 mg (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.

Mobocertinib 40 mg, Phase 1 Part

Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.

Mobocertinib 120 mg, Phase 1 Part

Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.

Mobocertinib 160 mg, Phase 1 Part

Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

Mobocertinib 160 mg, Phase 2 Part

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

Cancer stage is a measure of disease progression. The later stage indicates more advanced cancer. So, the Participants with Stage IV cancer had more advanced disease than stage III participants. The letters represent sub groups within a given stage, with B representing more advanced cancer than A. Other: Unknown or not staged.

Disease Stage at Screening

Time Since Initial Diagnosis

ECOG-PS assessed participant's performance status scale of 0 to 5: 0=Fully active/able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\> \[greater than\] 50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. A higher score indicated greater functional impairment.

Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Central Nervous System (CNS) involvement at Screening

Participants with NSCLC were categorized into adenocarcinoma, adenosquamous carcinoma, large cell, squamous, unknown and other.

Histopathological Classification of NSCLC

Smoking History

The safety population included all participants who received at least 1 dose of mobocertinib.

Mobocertinib 40, 120 or 160 mg capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.

Mobocertinib, Phase 1 Part: All Participants

The dose-limiting toxicity (DLT)-evaluable population included all participants who received at least 75 percent (%) of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part: Recommended Phase 2 Dose (RP2D) of Orally Administered Mobocertinib

The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 2 Part of the study.

Phase 2 Part: Confirmed Objective Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)

The safety population included all participants who received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

The DLT-evaluable population included as all participants who received at least 75% of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part: Number of Participants With First Cycle DLTs Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.00

Phase 1 Part: Number of DLTs for Mobocertinib Based on NCI CTCAE, Version 5.00

The DLT-evaluable population was defined as all participants who received at least 75% of their planned mobocertinib doses for their first cycle of treatment (unless interrupted by study drug-related AEs). As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part: Maximum Tolerated Dose (MTD) of Orally Administered Mobocertinib

AP32960

AP32914

The pharmacokinetic (PK) population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. As planned, this outcome measure was assessed only for Phase 1 Part of the study

Phase 1 Part, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose

Mobocertinib 120 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle disease until progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC.

The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part, Tmax: Time of First Occurrence of Cmax for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose

The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part, AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) After a Single Oral Dose

The PK population included all participants for whom there were sufficient dosing and mobocertinib concentration-time data to reliably estimate the PK parameters. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of the study.

Phase 1 Part, Cmax, ss: Maximum Observed Plasma Concentration for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses

Phase 1 Part, Tmax, ss: Time of First Occurrence of Cmax for Mobocertinib Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses

Phase 1 Part, AUC24, ss: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses

Phase 1 Part, Rac (AUC 24): Extent of Accumulation Ratio Based on AUC 24 on Multiple Dosing for Mobocertinib and Its Active Metabolites (AP32960 and AP32914) at Steady State After Multiple Oral Doses

The response-evaluable population was defined as participants who received at least 1 dose of mobocertinib, had measurable disease at baseline, and at least 1 post-baseline response assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. As planned, this outcome measure was assessed only for Phase 1 Part of study.

Phase 1 Part: ORR in Participants With EGFR Mutations as Assessed by Investigator

Phase 1 Part: ORR in Participants With HER2 Mutations as Assessed by Investigator

The centrally confirmed population was defined as the participants who had confirmed harboring EGFR exon 20 insertion mutation by central test and had received at least 1 dose of mobocertinib. As planned, this outcome measure was assessed only for Phase 2 Part of the study.

Phase 2 Part: Confirmed ORR as Assessed by the Investigator

Phase 2 Part: Duration of Response (DOR) as Assessed by the IRC as Per RECIST V1.1

Phase 2 Part: DOR as Assessed by Investigator as Per RECIST V1.1

Phase 2 Part: Time to Response as Assessed by the IRC as Per RECIST V1.1

Phase 2 Part: Time to Response as Assessed by the Investigator Per RECIST V1.1

Phase 2 Part: Disease Control Rate (DCR) as Assessed by the IRC as Per RECIST V1.1

Phase 2 Part: DCR as Assessed by the Investigator Per RECIST V1.1

Mobocertinib 160 mg, capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle until disease progression or intolerable toxicity, or another discontinuation criterion in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

Phase 2 Part: Progression Free Survival (PFS) as Assessed by the IRC as Per RECIST V1.1

Phase 2 Part: PFS as Assessed by the Investigator as Per RECIST V1.1

Phase 2 Part: Overall Survival (OS)

Global Health Status: Baseline

Global Health Status: Change from Baseline at 30 Days After Last Dose

Physical Functioning: Baseline

Physical Functioning: Change from Baseline at 30 Days After Last Dose

Role Functioning: Baseline

Role Functioning: Change from Baseline at 30 Days After Last Dose

Emotional Functioning: Baseline

Emotional Functioning: Change from Baseline at 30 Days After Last Dose

Cognitive Functioning: Baseline

Cognitive Functioning: Change from Baseline at 30 Days After Last Dose

Social Functioning: Baseline

Social Functioning: Change from Baseline at 30 Days After Last Dose

Fatigue: Baseline

Fatigue: Change from Baseline at 30 Days After Last Dose

Nausea and Vomiting: Baseline

Nausea and Vomiting: Change from Baseline at 30 Days After Last Dose

Pain: Baseline

Pain: Change from Baseline at 30 Days After Last Dose

Dyspnoea: Baseline

Dyspnoea: Change from Baseline at 30 Days After Last Dose

Insomnia: Baseline

Insomnia: Change from Baseline at 30 Days After Last Dose

Appetite Loss: Baseline

Appetite Loss: Change from Baseline at 30 Days After Last Dose

Constipation: Baseline

Constipation: Change from Baseline at 30 Days After Last Dose

Diarrhoea: Baseline

Diarrhoea: Change from Baseline at 30 Days After Last Dose

Financial Difficulties: Baseline

Financial Difficulties: Change from Baseline at 30 Days After Last Dose

FAS included all participants who received at least one dose of mobocertinib. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 2 Part of the study.

Phase 2 Part: Change From Baseline in Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Coughing: Baseline

Coughing: Change from Baseline at 30 Days After Last Dose

Haemoptysis: Baseline

Haemoptysis: Change from Baseline at 30 Days After Last Dose

Sore Mouth: Baseline

Sore Mouth: Change from Baseline at 30 Days After Last Dose

Dysphagia: Baseline

Dysphagia: Change from Baseline at 30 Days After Last Dose

Peripheral Neuropathy: Baseline

Peripheral Neuropathy: Change from Baseline at 30 Days After Last Dose

Alopecia: Baseline

Alopecia: Change from Baseline at 30 Days After Last Dose

Pain in Chest: Baseline

Pain in Chest: Change from Baseline at 30 Days After Last Dose

Pain in Arm or Shoulder: Baseline

Pain in Arm or Shoulder: Change from Baseline at 30 Days After Last Dose

Pain in Other Parts: Baseline

Pain in Other Parts: Change from Baseline at 30 Days After Last Dose

The full analysis set (FAS) included all participants who received at least one dose of mobocertinib. Here number analyzed 'n' signifies participants who were evaluable for specified categories. As planned, this outcome measure was assessed only for Phase 2 Part of the study.

Phase 2 Part: Change From Baseline in Patient-reported Symptoms (Particular Core Symptoms of Lung Cancer), Functioning, and HRQoL as Assessed by the EORTC Lung Cancer Module QLQ-LC13

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Chart Review Study of Adults With Advanced NSCLC	NCT05207423	Non-small Cell ...		18 Years -	Takeda
A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer	NCT03807778	Non-Small Cell ...	Mobocertinib	20 Years -	Takeda

Spots Global Cancer Trial Database for mobocertinib

Every month we try and update this database with for mobocertinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.