Trial Outcomes & Findings for Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer (NCT NCT03088930)

NCT ID: NCT03088930

Last Updated: 2022-02-11

Results Overview

Participants' tumor response to treatment will be compared from initial/pretreatment scan to 6 week scan using RECIST 1.1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2022-02-11

Participant Flow

Participant milestones

Measure	Neoadjuvant Treatment With Crizotinib Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Participants' tumor response to treatment will be compared from initial/pretreatment scan to 6 week scan using RECIST 1.1

Outcome measures

Measure

Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.

The Number of Participants With an Objective Tumor Response Rate

3 participants

SECONDARY outcome

Timeframe: 37 months

Pathologic response rate is defined as < 50% of viable tumor present histologically in the resected tumor specimen.

Outcome measures

Measure

Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.

The Number of Participants With Pathologic Response Rate

0 Participants

SECONDARY outcome

Timeframe: 6 weeks post treatment

Number of participants with response rate per RECIST 1.1

Outcome measures

Measure

Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.

Number of Participants With an Objective Response Rate

0 participants

SECONDARY outcome

Timeframe: 37 months

DFS is defined as the time from treatment to the first of either disease recurrence or death from any cause.

Outcome measures

Measure

Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.

The Number of Participants With Disease-free Survival (DFS)

0 Participants

SECONDARY outcome

Timeframe: 37 months

OS is defined as the time from study enrollment to death from any cause.

Outcome measures

Measure

Neoadjuvant Treatment With Crizotinib n=3 Participants Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.

Overall Survival (OS) Measured in Months

37 months Interval 0.0 to 37.0

Adverse Events

Neoadjuvant Treatment With Crizotinib

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neoadjuvant Treatment With Crizotinib n=3 participants at risk Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Crizotinib: Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 3 years
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • 3 years
General disorders Insomnia	33.3% 1/3 • Number of events 1 • 3 years
Respiratory, thoracic and mediastinal disorders Influenza	33.3% 1/3 • Number of events 1 • 3 years
Blood and lymphatic system disorders creatinine increased	33.3% 1/3 • Number of events 1 • 3 years
Respiratory, thoracic and mediastinal disorders cough	33.3% 1/3 • Number of events 1 • 3 years
Eye disorders blurred vision	66.7% 2/3 • Number of events 2 • 3 years
General disorders headache	33.3% 1/3 • Number of events 1 • 3 years
Gastrointestinal disorders epigastric discomfort	33.3% 1/3 • Number of events 1 • 3 years
Cardiac disorders bradycardia	33.3% 1/3 • Number of events 1 • 3 years
Blood and lymphatic system disorders ALT increased	33.3% 1/3 • Number of events 2 • 3 years
Gastrointestinal disorders dysgeusia	33.3% 1/3 • Number of events 1 • 3 years
Skin and subcutaneous tissue disorders dermatitis	33.3% 1/3 • Number of events 1 • 3 years
General disorders fatigue	33.3% 1/3 • Number of events 1 • 3 years

Additional Information

Dr. Tejas Patil

University of Colorado Cancer Center

Phone: 7208489264

Email: tajas.patil@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place