Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Protein Kinase Inhibitors

Efatutazone

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily

CS-7017 from 0.25 mg to 0.50 mg twice daily

CS-7017

Erlotinib

Global Clinical Leader

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.

After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.

After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.

After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.

As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as

≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR.

Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first.

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship

ICON Clinical Research

Daiichi Sankyo Co., Ltd.

Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.

Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.

CS-7017 0.25 mg BID; Initial Portion

Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.

CS-7017 0.50 mg BID; Initial Portion

CS-7017 0.50 mg BID; Additional Portion

Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).

CS-7017 0.50 mg BID; Initial + Additional Portions

All participants who received CS-71017 in combination with erlotinib.

Overall

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

South Korea

Region of Enrollment

Baseline characteristics are reported for participants in the Safety Analysis Set.

Contact for Clinical Trial Information

At least one CS-7017-Relaed TEAE

Blood and Lymphatic System Disorders

Anaemia

Thrombocytopenia

Neutropenia

Metabolism and Nutrition Disorders

Decreased appetite

Hypokalaemia

Hyponatraemia

Eye Disorders

Conjunctival hyperaemia

Cardiac Disorders

Pericardial effusion

Sinus arrhythmia

Respiratory, Thoracic, and Mediastinal Disorders

Pleural effusion

Gastrointestinal Disorders

Nausea

Renal and Urinary Disorders

Azotaemia

Congenital, Familial, and Genetic Disorders

Hydrocele

General Disorders & Administration Site Conditions

Face oedema

Oedema peripheral

Fatigue

Generalised oedema

Malaise

Investigations

Weight increased

Blood creatinine increased

Blood creatinine phosphokinase increased

Brain natriuretic peptide increased

Electrocardiogram QT prolonged

CS-7017-related TEAEs were assessed in the Safety Analysis Set.

CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy

Cycle 1, Week 1: AUClast

Cycle 1, Week 1: AUCtau

Cycle 2, Week 4: AUClast

Cycle 2, Week 4: AUCtau

Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

Cycle 1, Week 1: Cmax

Cycle 2, Week 4: Cmax,ss

Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

Cycle 1, Week 1: Tmax

Cycle 2, Week 4: Tmax,ss

Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

Partial response (PR)

Stable disease (SD)

Progressive disesae (PD)

Response rate (CR+PR)

Best overall response and response rate were assessed in the Efficacy Analysis Set.

Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

Per-protocol Progression-free Survival Time data was only assessed in the 0.50 mg BID (additional portion) and the 0.5 mg BID (initial and additional portions) Groups.

Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

At least one erolitinib-related TEAE

Infections and Infestations

Paronychia

Blepharitis

Dry eye

Nasal dryness

Nasal inflammation

Oropharyngeal pain

Diarrhoea

Anorectal discomfort

Flatulence

Stomatitis

Skin and Subcutaneous Tissue Disorders

Skin exfoliation

Dry skin

Rash

Dermatitis acneiform

Pruritus

Alopecia

Erlotinib-related TEAEs were assessed in the Safety Analysis Set.

Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy

Overall Study

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