Trial Outcomes & Findings for Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance (NCT NCT03833934)

NCT ID: NCT03833934

Last Updated: 2025-10-02

Results Overview

To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression

• Recruitment status: COMPLETED
• Target enrollment: 62 participants
• Primary outcome timeframe: 32 months
• Results posted on: 2025-10-02

Participant Flow

Participants were referred by means of their treating physician or social media to a study website (https://alcmi.net/research/spacewalk-study/) and completed a contact form indicating their interest in participating in the study and answered a prescreening questionnaire. If the patients indicated they have ALK-positive NSCLC and are progressing on an ALK TKI, they were contacted by the study staff who then released access to an online consent form to the patient.

Participant milestones

Measure	ALK-positive NSCLC With Progression Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ALK-positive NSCLC With Progression n=62 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Age, Continuous	55 years n=62 Participants
Sex: Female, Male Female	22 Participants n=62 Participants
Sex: Female, Male Male	40 Participants n=62 Participants
Region of Enrollment United States	62 participants n=62 Participants
Subjects diagnosed with Advanced ALK positive NSCLC with progression	62 participants n=62 Participants

PRIMARY outcome

Timeframe: 32 months

To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression

Outcome measures

Measure	ALK-positive NSCLC With Progression n=62 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Prevalence of ALK Fusion	27 Participants

PRIMARY outcome

Timeframe: 32 months

Population: Patients with detected ALK fusion

To determine the relative percentage of the ALK fusion within the cohort's gene pool

Outcome measures

Measure	ALK-positive NSCLC With Progression n=27 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
ALK Fusion Allelic Frequency	2.6 percentage of the ALK fusion Interval 0.1 to 37.0

PRIMARY outcome

Timeframe: 32 months

Population: Patients with detected ALK fusion

To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS

Outcome measures

Measure	ALK-positive NSCLC With Progression n=27 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion	17 Participants

PRIMARY outcome

Timeframe: 32 months

Population: Patients with detected ALK fusion

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Outcome measures

Measure	ALK-positive NSCLC With Progression n=27 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations	8 Participants

PRIMARY outcome

Timeframe: 32 months

Population: Patients with detected ALK fusion

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Outcome measures

Measure	ALK-positive NSCLC With Progression n=27 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance	6 Participants

PRIMARY outcome

Timeframe: 32 months

Population: Patients with detected ALK fusion

To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS

Outcome measures

Measure	ALK-positive NSCLC With Progression n=27 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Prevalance of ALK Restance Mechanism: Bypass Track Resistance	3 Participants

SECONDARY outcome

Timeframe: 32 months

Population: Patients with at least 3 months of follow-up time

Initiated a new ALK tyrosine kinase inhibitor for treatment of NSCLC following enrollment in the study

Outcome measures

Measure	ALK-positive NSCLC With Progression n=59 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Changed Treatment for NSCLC	49 Participants

SECONDARY outcome

Timeframe: 32 months

Population: Patients who had additional optional blood draw following initiation of new ALK TKI therapy

New ALK TKI treatment resulted in >50% reduction of ALK fusion allelle frequency

Outcome measures

Measure	ALK-positive NSCLC With Progression n=14 Participants Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)
Treatment Outcome: >50% Reduction of ALK Fusion Allelle Frequency	7 Participants

Adverse Events

ALK-positive NSCLC With Progression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ericka Izzo, Clinical Project Manager

Addario Lung Cancer Medical Institute (ALCMI)

Phone: 941-713-1225

Email: eizzo@alcmi.org

Results disclosure agreements

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