Prospective Clinicogenomic Program (PCG)

• ClinicalTrials.gov Identifier: NCT04180176
• Recruitment Status: Active, not recruiting
• First Posted: November 27, 2019
• Last Update Posted: January 26, 2023
• Sponsor: Genentech, Inc.
• Collaborator: Flatiron Health, Inc.; Foundation Medicine, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: November 19, 2019
• First Posted Date: November 27, 2019
• Last Update Posted Date: January 26, 2023
• Actual Study Start Date: December 13, 2019
• Estimated Primary Completion Date: March 27, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 25, 2019)

• Proportion of Potential Eligible Participant Enrollment [ Time Frame: Up to 5 years ]
• Proportion of Enrolled Participants Submitting Sufficient Blood Samples [ Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years. ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 25, 2019): Blood Level of ctDNA [ Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years. ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Clinicogenomic Program
• Official Title: A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
• Brief Summary: The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Non-Small Cell Lung Cancer (NSCLC)
• Small-Cell Lung Cancer (SCLC)

Intervention

Other: Blood Draw

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Study Arms

• Experimental: All-Comer Cohort
  Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
  Intervention: Other: Blood Draw
• Experimental: Front-line Immunotherapy Re-enrollment Cohort
  Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.
  Intervention: Other: Blood Draw

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 25, 2019): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 27, 2025
• Estimated Primary Completion Date: March 27, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Documented diagnosis of mNSCLC or ES-SCLC
• Planned initiation of SOC systemic anti-cancer treatment
• Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

Exclusion Criteria:

- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04180176
• Other Study ID Numbers: GX41563
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Flatiron Health, Inc.; Foundation Medicine, Inc.

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: January 2023