Trial Outcomes & Findings for TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003) (NCT NCT02920476)

NCT ID: NCT02920476

Last Updated: 2022-06-23

Results Overview

To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

1 year

Results posted on

2022-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=4 Participants TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Age, Continuous	66.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Only 2 of the 4 subjects accrued to the study were evaluable for treatment response.

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Objective Response Rate (ORR)	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Only 2 of the 4 participants accrued were evaluable for this outcome measure.

To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Clinical Benefit Rate	0 Participants

SECONDARY outcome

Timeframe: 1095 days

To determine the overall survival in days

Outcome measures

Outcome measures
Measure	Treatment Arm n=4 Participants TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Overall Survival (OS)	449.25 days Interval 165.0 to 1095.0

Adverse Events

Treatment Arm

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=4 participants at risk TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
Musculoskeletal and connective tissue disorders Shoulder pain	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Infections and infestations Respiratory infection	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
General disorders Non-cardiac chest pain	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.

Other adverse events

Other adverse events
Measure	Treatment Arm n=4 participants at risk TAS-102 TAS-102: Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals. Days 6 through 7: Rest Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Rest
General disorders Non-cardiac chest pain	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Gastrointestinal disorders Bloating	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Gastrointestinal disorders Constipation	75.0% 3/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Nervous system disorders Dysgeusia	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
General disorders Fatigue	50.0% 2/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
General disorders Fever	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Vascular disorders Hot flashes	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Gastrointestinal disorders Nausea	75.0% 3/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Investigations Neutrophil count decreased	50.0% 2/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Investigations Platelet count decreased	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Nervous system disorders Tremor	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Gastrointestinal disorders Vomiting	100.0% 4/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 1/4 • Adverse event data were collected from the time that informed consent was signed until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time period over which adverse event data was collected ranged from 165 to 1,095 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place