Trial Outcomes & Findings for Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer (NCT NCT02762877)

Last Updated: 2020-11-17

Results Overview

Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.

Recruitment status

TERMINATED

Target enrollment

140 participants

Primary outcome timeframe

Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	A - NSCLC All Comers Regardless of Genomic Alteration Status Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)	B - Progressing on EGFR Targeted Therapies Patients with non-squamous NSCLC progressing on erlotinib, gefitinib, or afatinib
Overall Study STARTED	121	19
Overall Study COMPLETED	121	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A - NSCLC All Comers Regardless of Genomic Alteration Status n=121 Participants Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)	B - Progressing on EGFR Targeted Therapies n=19 Participants Patients with non-squamous NSCLC progressing on erlotinib, gefitinib, or afatinib	Total n=140 Participants Total of all reporting groups
Age, Customized Age, years	66 years n=5 Participants	67 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	10 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	9 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	91 Participants n=5 Participants	12 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	6 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	9 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	6 Participants n=7 Participants	31 Participants n=5 Participants
EGFR Mutation Tested	117 Participants n=5 Participants	19 Participants n=7 Participants	136 Participants n=5 Participants
ALK-EML4 Fusion Mutation Tested	115 Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks

Population: Subjects who received EGFR mutation testing on both their tissue and plasma samples.

Outcome measures

Outcome measures
Measure	A - NSCLC All Comers Regardless of Genomic Alteration Status n=117 Participants Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
Concordance of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment	94.0 Overall percent agreement (OPA) Interval 88.1 to 97.6

SECONDARY outcome

Timeframe: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks

Population: Subjects who received ALK (EML4-ALK fusion) mutation testing on both their tissue and plasma samples.

Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.

Outcome measures

Outcome measures
Measure	A - NSCLC All Comers Regardless of Genomic Alteration Status n=115 Participants Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.	95.7 Overall percent agreement (OPA) Interval 90.1 to 98.6

SECONDARY outcome

Timeframe: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)

Population: Non-squamous NSCLC patients who progressed on erlotinib, gefitinib, or afatinib treatment and received mutation testing on both their plasma and tissue samples.

Detection of EGFR T790M alterations in plasma using the OncotypeSEQ Liquid Select assay. Progression on EGFR targeting therapy (erlotinib, gefitinib, afatinib) assessed clinically or radiologically

Outcome measures

Outcome measures
Measure	A - NSCLC All Comers Regardless of Genomic Alteration Status n=19 Participants Patients with non-squamous NSCLC regardless of genomic alteration status (newly diagnosed or progressing on therapy)
Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).	32 percentage of participants

Adverse Events

A - NSCLC All Comers Regardless of Genomic Alteration Status

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B - Progressing on EGFR Targeted Therapies

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

Director of Clinical Trials

Genomic Health, Inc.

Phone: 1.650.569.2042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60