Genomic Profiling in Previously Untreated Metastatic Non-small Cell Lung Cancer

NCT02671045 | Terminated

• 1 other identifier: COTA 14001
• Study Type: observational
• Target: 649
• Locations: 1 country
• Sites: 1

Brief Summary

Overall survival rates for patients with metastatic NSCLC are poor utilizing conventional cytotoxic chemotherapy approaches. However, a subset of patients harbor genomic driver mutations, which when targeted with specific therapies, experience improved outcomes. Unfortunately, identification of these mutations, although recommended in national guidelines, has been limited for a variety of factors including small biopsy samples. The broad application of a sensitive genomic profiling test, which simultaneously examines for multiple genomic alterations on limited biopsy material, could increase the identification of patients with actionable mutations and thereby improve survival in NSCLC. The FoundationOne test meets these requirements. A recent study using the FoundationOne assay identified a significant number of actionable mutations among NSCLC patients who were previously thought to be negative for mutations when tested using other approaches. This is a non-randomized observational comparative study with various cohorts based on physician diagnostic patterns of care and biologic genomic profile status. Survival and cost information will be compared based on different use of genomic profiling.

Conditions

Carcinoma, Non-small Cell Lung

Keywords

lung cancer; genomic profile; targeted therapy; FoundationOne

Outcome Measures

Primary Outcomes (1)

• Number of participants with all cause mortality

  Comparison by cohorts

  Completion of study (estimated 5 years)

Secondary Outcomes (8)

• Number of participants with a mutation of EGFR

  5 years

• Number of paticipants with a rearrangment of ALK

  5 years

• Number of participants with a genomic alteration with an available targeted therapy (as defined by NCCN guideline matching)

  5 years

• Number of participants that receive a targeted therapy for a genomic mutation (as defined by NCCN guideline matching)

  5 years

• ECOG performance scores

  5 years

Study Arms (7)

A - Genomic profile by FoundationOne

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified and the patient/physician agree to receive the targeted therapy

Genetic: Genomic profile by FoundationOne

B - Genomic profiling by FoundationOne

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and an actionable target has been identified. However, the patient does not receive the targeted therapy.

Genetic: Genomic profile by FoundationOne

C - Genomic profiling by FoundationOne

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling using FoundationOne and no actionable target has been identified.

Genetic: Genomic profile by FoundationOne

D - Genomic profile by other methods

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified and the patient/physician agrees to receive the targeted therapy.

Genetic: Genomic profile by other methods

E - Genomic profile by other methods

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target has been identified. However, the patient does not receive targeted therapy.

Genetic: Genomic profile by other methods

F - Genomic profile by other methods

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has been sent for genomic profiling but NOT using FoundationOne and an actionable target NOT has been identified.

Genetic: Genomic profile by other methods

G - No genomic profiling

The patient's lung cancer specimen which was obtained at the time of documented metastatic disease has not been sent for genomic profiling.

Interventions

Genomic profile by FoundationOne GENETIC

Proprietary comprehensive genomic profile.

Also known as: FoundationOne

A - Genomic profile by FoundationOne; B - Genomic profiling by FoundationOne; C - Genomic profiling by FoundationOne

Genomic profile by other methods GENETIC

Genomic profiling by other testing methods.

Also known as: Other methodology

D - Genomic profile by other methods; E - Genomic profile by other methods; F - Genomic profile by other methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All (consecutive) adult patients with untreated metastatic non-small cell lung cancer treated at a COTA center will be considered enrolled on the trial starting with enrollment of the index subject and continuing until study enrollment is completed.

You may qualify if:

• Pathologic confirmation of non-small lung cancer (all histologies)
• Age ≥ 18 years at the time of treatment at a COTA center
• Documentation of metastatic (stage IV) disease
• Untreated metastatic disease prior to the genomic testing. No treatment for metastatic lung cancer is permitted prior to genomic profiling. Prior therapy for stage 0-III lung cancer is permitted.
• Second malignancy eligible if prior malignancy has been stable off therapy for ≥ 6 months.

You may not qualify if:

• Small cell lung cancer histology
• Non-metastatic or completely resected lung cancer
• Treatment for metastatic disease prior to genomic testing.
• Active second malignancy requiring therapy less than 6 months prior to lung cancer diagnosis
• Patients may refuse to be tracked in the COTA database and/or participate in this observational study.

Sponsors & Collaborators

• Cota Inc.: lead
• Regional Cancer Care Associates LLC: collaborator
• Foundation Medicine: collaborator
• Horizon Blue Cross Blue Shield of New Jersey: collaborator

Study Sites (1)

COTA

New York, New York, 10004, United States

Location

Related Publications (2)

• Drilon A, Wang L, Arcila ME, Balasubramanian S, Greenbowe JR, Ross JS, Stephens P, Lipson D, Miller VA, Kris MG, Ladanyi M, Rizvi NA. Broad, Hybrid Capture-Based Next-Generation Sequencing Identifies Actionable Genomic Alterations in Lung Adenocarcinomas Otherwise Negative for Such Alterations by Other Genomic Testing Approaches. Clin Cancer Res. 2015 Aug 15;21(16):3631-9. doi: 10.1158/1078-0432.CCR-14-2683. Epub 2015 Jan 7.

  PMID: 25567908 BACKGROUND

• Gutierez M, Harper H, Halliby BE. Impact and utilization of genomic profiling in metastatic non-small cell lung cancer in the community setting. J Clin Oncol 33, 2015 (suppl; abstr e19113)

  BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martin Gutierez, MD

  John Theurer Cancer Center at Hackensack University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: February 2, 2016
• Study Start: April 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)